Efficacy of Delivery Room Bubble Continuous Positive Airway Pressure in Preterm Neonates <34 Weeks Having Respiratory Distress
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

i 
 
  Bangabandhu Sheikh Mujib Medical University 
                                    Shahbagh, Dhaka -1000 
 
Application for Institutional Review Board (I.R.B) Clearance 
Title of the study          :  Efficacy of delivery room bubble continuous 
positive airway pressure in preterm neonates <34 weeks having respiratory 
distress  
        Principal Investigator  
       :   Dr. Nuzhat Nuary Jui 
1. Name of present course               :    MD-Neonatology 
2. Joining date in thesis part            :   March, 2025 
3. Name of Institute                         : Bangabandhu Sheikh Mujib Medical University 
4. Expected Date of Examination   : November, 2026 
5. Guide                            : Asso. Prof. Dr. Sadeka Choudhury Moni  
                                                                 Associate Professor,  
                                                                Department of Neonatology, BSMMU. 
6. Place of the Study      :     Department of Neonatology, BSMMU.    
8.Type of the study        : Randomized controlled trial 
9.Duration  
:   
 1  Year 
10.Total cost  
:  
2,82,980   
11.Funding Agency (lf Applicable)   : Self 
We agree to obtain approval of the Institutional Review Board of BSMMU for 
any changes involving the rights and welfare of subjects or any changes of the 
Methodology before making any such changes. 
Principal Investigator                           Guide: 
 
Register No :     4724 
Received Date : 10/08/25 
Meeting Date : 15/08/25 
Approved : 23/08/25 
Dr. Nuzhat Nuary Jui 
Resident, MD (Phase - B) 
Department of Neonatology 
BSMMU, Shahbag, Dhaka. 
Asso. Prof. Dr. Sadeka Choudhury Moni 
Associate Professor  
Department of Neonatology 
BSMMU, Shahbag,  

ii 
 
Application to the Chairman 
 
Date : 10/08/25 
To 
The Chairman 
Department of Neonatology 
Bangabandhu Sheikh Mujib Medical University (BSMMU) 
Shahbagh, Dhaka 
 
Subject:  Permission for conducting a research work 
 
Sir, 
Assalamu alaikum, I would like to conduct a research work titled ‘Efficacy of delivery 
room bubble continuous positive airway pressure in preterm neonates <34 weeks 
having respiratory distress’ over a period of 1 (one) years in the department of 
Neonatology. 
 
It would be my privilege if you kindly allow me to conduct the research work in your 
department for the above mentioned period. 
 
 
Sincerely yours 
 
 
Dr. Nuzhat Nuary Jui 
Resident 
Department of Neonatology 
Bangabandhu Sheikh Mujib Medical University  
Shahbagh, Dhaka. 
 
 
 
 
 
 
To 

iii 
 
The Chairman  
Institutional Review Board (IRB) and Pro- VC (Academic) 
Bangabandhu Sheikh Mujib Medical University (BSMMU) 
Shahbagh, Dhaka - 1000. 
 
Subject: Submission of a Research proposal for IRB clearance 
 
 
Dear Sir, 
Dr. Nuzhat Nuary Jui, working as a resident, Department of Neonatology of BSMMU, 
submitted a research proposal titled ‘Efficacy of delivery room bubble continuous 
positive airway pressure in preterm neonates <34 weeks having respiratory 
distress to obtain IRB clearance. 
 
I am forwarding this research proposal for your kind perusal and necessary action.  
 
 
 
Thanking you,  
 
 
Professor Dr. Sanjoy Kumer dey  
Chairman 
Department of Neonatology  
Bangabandhu Sheikh Mujib Medical University 
Shahbagh, Dhaka- 1000, Bangladesh. 

iv 
 
 
Put Tick sign (√) appropriate answers against each of the following statement 
(If not Applicable, Please write NA) 
 
1. Source of Population: 
 
   
4. Are subjects clearly     
    informed about: 
 
 
   (a) Patients 
      Yes 
      No 
   (a) Nature and purposes of  
        Study 
      Yes 
      No 
   (b) Healthy Subjects 
      Yes 
      No 
   (b) Procedures to be  
         followed including  
         alternative used 
     Yes 
      No 
   (c) Minors or person under  
           guardianship   
      Yes 
      No 
   (c) Physical risks 
     Yes 
      No 
 
      
 
   (d) Private questions 
     Yes 
      No 
2. Does the study involve: 
    
  
   (e) Mental risks 
     Yes 
      No 
   (a) Physical risks to the     
         subjects   
      Yes 
      No 
   (f) Benefits to be derived 
     Yes 
      No 
   (b) Social Risks 
      Yes 
      No 
   (g) Right to refuse to  
        participate or to  
        withdraw from study 
     Yes 
      No 
   (c) Psychological risks 
      Yes 
      No 
   (h) Confidential handling  
       of data 
     Yes 
      No 
   (d) Discomfort to subjects 
      Yes 
      No 
   (i) Compensations:              
        (where there are risks     
         or loss of working time   
        or privacy is involved  
        in any particular  
         procedure) 
     Yes 
      No 
   (e) Invasion of the body 
      Yes 
      No 
 
    
  
   (f) Invasion of Privacy 
      Yes 
      No 
5.Signed consent form will  
     be obtained: 
 
 
   (g) Disclosure of   
        information  damaging    
        to subject or others 
      Yes 
      No 
   (a) From Subjects  
        (If adult) 
     Yes 
      No 
3. Does the study involve
 
 
 
 
   (b) From parent or   
        guardian  
     (if  subjects are minor) 
     Yes 
      No 
   (a) Use of records:-  
       (Hospital, Medical,    
        Death, Birth or other) 
      Yes 
      No 
 
 
 
   (b) Use of foetal tissues or  
        Abortus 
      Yes 
      No 
6. Will precautions be  
    taken to protect   
    anonymity of subjects? 
     Yes 
   
      No 
      
   (c) Use of organs body/fluid  
         
      Yes 
      No 
 
  
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v 
 
Abstract for Institutional Review Board 
Continuous Positive Airway Pressure (CPAP) is a well-established mode of respiratory 
support in preterm newborns. Early continuous positive airway pressure (CPAP) has 
proven to be beneficial in reducing ventilator dependence and subsequent chronic 
lung disease in neonates suffering from Respiratory distress.   
 In preterm infants, both immature development of the airways and chest and 
limited surfactant secretion result in a strong tendency to lung collapse with 
restriction of residual functional capacity. The use of continuous positive airway 
pressure (CPAP) has been pointed out as a suitable option to prevent loss of 
pulmonary volume and to minimize the use of mechanical ventilation and of 
surfactant. In theory, the earlier that CPAP applied, the lower the tendency for loss 
of residual functional capacity and the easier the respiratory stabilization of preterm 
infants.  
 
Objective: 
 
To evaluate the efficacy of delivery room  bubble continuous positive airway 
pressure (CPAP) in reducing  the  incidence of respiratory morbidity and mortality in 
preterm neonate during the hospital stay in early neonatal period.   
 
 
Methodology: This randomized controlled clinical trial will be conducted in Neonatal 
Intensive Care Unit (NICU) and Department of Obstetrics & Gynecology of 
Bangabandhu Sheikh Mujib Medical University, a tertiary care hospital of Dhaka city 
after approval by Institutional Review Board. The duration will be of one and half 
year. Preterm neonate gestational age less than 34 weeks fulfilling the inclusion 
criteria will been enrolled in the study after getting informed consent from the 
parents. Proper maternal history & neonatal characteristics will be recorded in data 
collection form. Delivery room CPAP of the enrolled babies will be started as early as 

vi 
 
possible within 10 minutes. Another group which is control group will be managed 
by supplemental O2 in delivery room. Both group will be enrolled by block 
randomization. Then the both group will be transferred to NICU with respiratory 
support and managed according to institutional protocol. Statistical analyses will be 
performed using the Statistical Package for Social Sciences (SPSS), version 25. 
 
Results: Results will be incorporated after the study.  
 
Conclusion: The conclusion will be incorporated after the study. 
 
 

vii 
 
 
Table of content 
Content 
Page 
no. 
Application to the Chairman 
ⅲ 
Abstract 
ⅵ-ⅶ 
 Content table 
ⅷ 
Introduction 
1 
Rationale of the study 
4 
Research question 
5 
Objectives, Methods and Materials 
6 
Selection of patients 
7 
Study variables 
8 
 Operational definitions  
10 
Ethical Consideration 
11 
 Study procedure 
12 
 Sample size calculation  
14 
Statistical analysis 
15 
 
 
Dummy tables 
   16 
Appendices: 
 
Data collection form 
ⅸ 
Informed consent form English 
ⅹⅳ 
Informed consent form Bangla 
ⅹⅶ 
References 
ⅹⅸ 
Time table of the study 
ⅹⅹⅰ 
List of abbreviation 
ⅹⅹⅱ 
Budget 
ⅹⅹⅲ 

1 
 
‘Efficacy of delivery room bubble continuous positive airway 
pressure in preterm neonates <34 weeks having respiratory distress: 
a single center randomized controlled clinical trial ‘ 
 
                                        Principal Investigator: 
Dr. Nuzhat Nuary Jui 
MD (Phase - B) 
Department of Neonatology 
BSMMU, Dhaka. 
 
 
 
 
 
 
 
 
Guide: 
Associate Professor Dr. Sadeka Choudhury Moni 
Associate Professor 
Department of Neonatology 
Bangabandhu Sheikh Mujib Medical University 
Shahbag, Dhaka- 1000, Bangladesh. 
 
 
 

2 
 
Title: ‘Efficacy of delivery room bubble continuous positive airway pressure in 
preterm neonates <34 weeks having respiratory distress: a single center 
randomized controlled clinical trial’ 
Introduction 
Continuous Positive Airway Pressure (CPAP) is a well-established mode of 
respiratory support in preterm newborns. Early continuous positive airway pressure 
(CPAP) has proven to be beneficial in reducing ventilator dependence and subsequent 
chronic lung disease in neonates suffering from Respiratory distress. 
 
In an attempt to prevent the injuries caused by mechanical ventilation, there has been 
a search for less aggressive (non-invasive) ways of providing respiratory support for 
preterm neonates who require respiratory support. The recent evidence supports use of 
continuous positive airway pressure (CPAP) for management of respiratory distress in 
these preterm neonates. CPAP generates a continuous distending pressure in the 
alveoli throughout the respiratory cycle. It splints the airways, improves lung 
compliance, conserves surfactant and reduces work of breathing. It prevents the loss 
of pulmonary volume and minimizes the use of mechanical ventilation and surfactant.  
bCPAP is a simple and cost effective respiratory support system (RSS) which consists 
of products that are easily available and health care provider can easily be trained to 
make and use this system. 
 
Globally, an estimated 15 million children are born prematurely each year and this 
number is rising and most of them (96%) are in developing countries. (Blencowe et al. 
2013) (WHO health statistics, 2018). Preterm birth and its complications are a leading 
cause of under-five mortality, causing more than one million deaths per year. In 
Bangladesh, 573,000 premature neonates born each year and 32 % of neonatal death 
occur from prematurity. 
 
 In preterm neonates, immature development of the airways and limited surfactant 
secretion result in a strong tendency to alveolar collapse with reduced functional 

3 
 
residual capacity. Many neonates born at <34 weeks gestation require respiratory 
support. 
 
Earlier application of the CPAP is supposed to the fact that, the lower the tendency for 
loss of functional residual capacity and the easier the respiratory stabilization of these 
preterm neonates. Early CPAP may be beneficial in reducing ventilator dependence 
and subsequent chronic lung disease in the extremely low birth weight (ELBW) 
neonates.  
 
Bubble CPAP (bCPAP) is the least expensive and least complicated CPAP option, 
making this the preferred technology in resource-limited settings. Early bubble CPAP 
reduced delivery room intubations, days on mechanical ventilation and postnatal 
steroid usage. It was associated with increased postnatal weight gain and no 
complications (Narendran et al 2013) 
 
B-CPAP was effective in the treatment of neonates who were suffering from 
respiratory distress and reduced the duration of hospital stay. In addition to mentioned 
benefits, its low cost may be the reason to use B-CPAP broadly compared with V-
CPAP. (Bahareh  et al 2013) 
 
 
 
Early nasal CPAP is an effective treatment of respiratory distress in very low birth 
weight neonates, significantly reducing the need for intubation and mechanical 
ventilation (Gittermann et al 2003) 
 
Early vs late CPAP: The application of CPAP early in the course of the disease before 
alveolar collapse occurs may work better than late CPAP by reducing lung damage 
and promoting lung function and surfactant pool. In the systematic review that 
compared early CPAP (starting CPAP at the time of randomization) vs. late CPAP 
(initiating late in the course of disease when FiO2 requirement is > 0.60), early CPAP 
was associated with a significant reduction in subsequent use of mechanical 

4 
 
ventilation [RR 0.55, (95% CI 0.32, 0.96); NNT 6]. But early CPAP had no effect on 
overall mortality, bronchopulmonary dysplasia (BPD) or pneumothorax (GUPTA, et 
al, 2015). 
    
                
 

5 
 
Rationale of the study 
In preterm infants, immature development of the airways and chest as well as limited 
surfactant secretion result in a strong tendency to lung collapse with restriction of 
residual functional capacity. In an attempt to prevent the injuries caused by 
mechanical ventilation, there has been a search for less aggressive ways of promoting 
respiratory support for these patients. The use of continuous positive airway pressure 
(CPAP) has been pointed out as a suitable option to prevent loss of pulmonary volume 
and to minimize the use of mechanical ventilation and of surfactant therapy. Again it 
is a simple, low-cost and effective alternative to improve the respiratory status of 
preterm infants with respiratory distress. Earlier application of CPAP is supposed to 
lower the tendency for loss of residual functional capacity and prevent atelectasis, so 
lesser pressure is required, which results in better gas exchange. Bubble CPAP is 
more cost effective, less intensive, requires less training and has lower risk of 
complications. 
 
In our country, neonatal care is expanding day by day. Total 59 numbers of SCANU 
has been established. The ultimate goal of these study is to better understand the role 
of bCPAP in reducing respiratory distress in resource-limited settings. This will help 
to improve implementation of bCPAP  and scale-up of this technology to reduce 
neonatal mortality and morbidity from respiratory illness. 
 
 
 
 
 
 
 
 
  

6 
 
Research question 
Does the use of bubble continuous positive airway pressure (bCPAP) in the delivery 
room reduce the incidence of respiratory morbidity and mortality of preterm neonate 
during early neonatal period? 
 
Hypothesis: 
Delivery room bubble CPAP reduces the incidence of respiratory morbidity and 
mortality of preterm neonate during early neonatal period. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

7 
 
Objectives 
General 
To examine the efficacy of delivery room bCPAP in preterm neonates with 
respiratory distress. 
Specific 
 To observe frequency of mechanical ventilator and surfactant administration 
in delivery room bCPAP group.  
 To observe frequency of mortality in early neonatal period in delivery room 
bCPAP group. 
 To observe frequency of mechanical ventilator and surfactant administration 
in delivery room supplemental O2 group.  
 To observe frequency of mortality in early neonatal period in delivery room 
supplemental O2 group. 
 To compare the respiratory outcome of both group. 
 
 
Materials and Methods 
 
Study design 
Randomized controlled clinical trial. 
Place of study 
 In the Department of Obstetrics & Gynecology, Bangabandhu Sheikh Mujib 
Medical University, Shahbagh, Dhaka, Bangladesh 
 In the Department of Neonatology, Bangabandhu Sheikh Mujib Medical 
University, Shahbagh, Dhaka, Bangladesh.  
Study period 
One and half year from approval of Institutional Review Board. 
 

8 
 
Study population 
Preterm neonate less than 34 weeks having respiratory distress after birth. 
 
 
Selection of patients 
Inclusion criteria:  
 
● Neonate gestational age less than 34 weeks delivered at BSMMU. 
● Having respiratory distress. 
● Neonate whose parents give consent to be enrolled in these study. 
 
Exclusion criteria:  
 
● Congenital anomaly such as cleft lip, cleft palate, congenital diaphragmatic hernia. 
● Newborn required delivery room intubation 
 
● Multiple gestation.  
 
● Neonate whose parents don’t give consent to be enrolled in these stud

9 
 
Study variable 
Dependent variable  
 Respiratory severity score ( Silverman score ) 
 Need for mechanical ventilation  
 Need for surfactant  
 Mortality within 7 days  
 Frequency of Apnea 
Independent variable 
  Antenatal factors 
1. Maternal diseases e.g.-Diabetes mellitus, Hypertension etc 
2. Antenatal corticosteroid. 
3. Chorioamnionitis 
 
Neonatal factors 
1. Gestational age (weeks) 
2. Birth weight (gram) 
3. Sex(male/female) 
4. APGAR Score at1st  and 5
thminute 
5. Fetal growth at birth ( SGA, AGA, LGA) 
6. Perinatal asphyxia  
7. Mode of resuscitation 
8. Necrotizing enterocolitis  
9. Length of hospital stay 
10. Patent ductus arteriosus  
 

10 
 
Operational definition 
Early Neonatal period: It is defined as period from birth to can be further 7 
completed days of birth. 
 
Gestational age: It is the time elapsed between the first day of the last menstrual 
period and the day of delivery. Gestational age is expressed in completed weeks 
(Gomella et al. 2013) 
Preterm neonate: Less than 37 completed weeks (less than 259 days) of gestation 
(World Health Organization, 2011). 
 
Birth weight is the first weight of the fetus or newborn obtained after birth. For live 
births, birth weight should preferably be measured within the first hour of life before 
significant postnatal weight loss has occurred.  
 
Respiratory Distress is defined as presence of any two of the following features such 
as respiratory distress more than 60 breath / min , subcostal / intercostal recession, 
expiratory grunting/groaning. (BSMMU protocol, AIMS protocol) 
 
Appropriate for gestational age (AGA) is defined as a birth weight between 10th 
and 90th percentile for infant’s gestational age.  
Small for gestational age (SGA) is defined as a birth weight below 10th percentile 
for infant’s gestational age.  
Large for gestational age (LGA) is defined as a birth weight above 90th percentile 
for infant’s gestational age.  
 
APGAR score is a measure of the physical condition of a newborn infant. APGAR 
stands for appearance, pulse or heart rate, grimace, activity and respiration of the 
newborn after birth assessed at 1
st  and 10
th min of life. It is obtained by adding points 
(2, 1 or 0) for these above-mentioned parameters. A score of 0-3 means mild 
respiratory distress, 4-7 moderate respiratory distress and >7 means severe respiratory 
distress  (Gomella, 2020). 
 

11 
 
Multiple gestations occur when more than one fetuses carried during a pregnancy 
(Gomella, 2020). 
Gestation diabetes mellitus (GDM) is defined as carbohydrate intolerance of variable 
severity first diagnosed during pregnancy (fasting blood sugar 7 mmol/L or above and 
2 hours after 75g glucose 11.1 mmol/L or above (Gomella,2020). 
 
Pregnancy induced hypertension (PIH) is manifested by hypertension (Blood 
pressure 140/90 mm Hg or more) without proteinuria after 20 weeks of gestation 
(Gomella, 2020). 
Intra ventricular hemorrhage (IVH) is defined as ultrasonographic evidence of 
germinal matrix hemorrhage (Gomella, 2020). 
 
 
 
 

12 
 
Ethical consideration 
There is a minimum physical, psychological, social and legal risk during taking 
history, physical examination, and investigations. Proper safety measures will be taken 
in every step of the study. The only researcher will be allowed to access the collected 
data. Ethical clearance will be obtained from the Institutional Review Board (IRB) of 
BSMMU to undertake the current study. According to Helsinki Declaration for 
Medical Research involving Human Subjects 1964, all the patients will be informed 
about the study design, the underlying hypothesis and the right of the participants to 
with draw themselves from the research at any time, for any reason. Informed written 
consent will be obtained from parents who will voluntarily provide consent to 
participate in this study. 
 
The following ethical issues will be addressed accordingly: 
 Strict confidentiality and security of data related to the patient will be 
maintained. 
 The presentation of data and information related to the patient will be 
documented anonymously. 
 The data analysis will be completed on the subjects who complete the study 
according to the protocol after recruitment of subjects with valid informed 
consent. 
 There is no additional risk or safety concern due to the research process to 
either patient or researcher. 
 There is no potential conflict of interest in this study and an entirely academic 
research project. 

13 
 
Study procedure 
This randomized controlled clinical trial will be conducted over eighteen months 
period in the Department of Neonatology and Department of Obstetrics & 
Gynecology, BSMMU, Dhaka after approval by IRB. An informed consent in local 
language from parents will be taken prior to enrollment of their neonates. The study 
included all spontaneously breathing preterm neonates (<34 completed weeks of 
gestational age) with mild to moderate respiratory distress  and neonates with critical 
congenital heart disease, congenital anomalies , congenital diaphragmatic hernia, 
newborn required delivery room intubation, multiple gestation will be excluded from 
the study. Preterm neonates fulfilling the inclusion criteria will be managed under 
radiant warmer and will be assessed for respiratory distress score and saturation will 
be monitored by attaching pulse oximeter. One group will be managed by initiated 
bubble CPAP and another group will be managed by supplemental O2. Respiratory 
support will be started within 10 minutes of birth. Selection will be done by block 
randomization. 
  
Subsequently the both group of neonates will be transferred to neonatal intensive care 
with same respiratory support. Then both group will be managed by institutional 
protocol. 
 
The primary outcomes will be evaluated whether they need surfactant therapy or 
mechanical ventilation or died in early neonatal period. The secondary outcomes to be 
evaluated are duration of CPAP, apnea and complication such as pneumothorax, 
patent ductus arteiosus and intra ventricular hemorrhage. These neonates will be 
compared to historical controls, matched for birth weight and gestational age.  
Data will be collected daily for 7days during hospital stay. 
 
 
 
 

14 
 
Sample size calculation 
n1 = (𝑍1−𝛼2
⁄ + 𝑍1−𝛽)
2 𝑝1(1−𝑝1)+𝑝2(1−𝑝2)
(𝑝1−𝑝2)2
 
Here,  
n = estimated sample size 
Proportion of Outcome of group 1 (p1) = 30 % (It is found out from previous study 
 Saumil Ashvinkumar Desai, Pankaj Tule, Ruchi Nimish Nanavati, 2017) 
 
Proportion of Outcome of group 2 (p2) = 67 % (It is found out from previous study 
Saumil Ashvinkumar Desai, Pankaj Tule, Ruchi Nimish Nanavati, 2017) 
Level of significance (α) = 0.05 
Power (1-β) = 0.80 
Z alpha value =1.96 
Z beta value = 0.84 
n1 = (1.96 + 0.84)2 0.3(1−0.3)+0.67(1−0.67)
(0.30−0.67)2
 
Sample size for group 1 (n1) = 25.3 
Sample size for group 1 (n2) = 25.3 
Attrition %= 20 % 
So,  
  So estimated total sample size for this study is 60. 
 

15 
 
Statistical analysis 
After collecting the data, it will be entered in a personal computer, then following 
steps will be used to analyze the collected data- 
Statistical analyses will be performed using the Statistical Package for Social Sciences 
(SPSS), version 25. Continuous variables will be presented as mean ± SD for normally 
distributed data and as median (interquartile range) for skewed data. Categorical 
variables will be presented as frequencies and percentages. The unpaired Student t test 
will be used for quantitative variables with a normal distribution and the Mann-
Whitney U test will be used for variables with a skewed distribution. The chi square 
test will be performed for qualitative variables. Result will be considered statistically 
significant if values of- P<0.05. Correlations between continuous variables will be 
performed by Pearson correlation coefficient (r). The predictive power of different 
variables will be assessed by receiver operating characteristic (ROC) curve. Logistic 
regression analysis will be used to test the association of variables with outcome. 

16 
 
Dummy tables 
Table 1:Comparison of  Maternal characteristics between delivery room group 
and control group 
Parameter 
Delivery room CPAP group   
Control Group (n=30)  
 
Control Group 
Cont
 
P value  
Maternal Age (years) 
Mode of delivery (%) NVD / 
cesarean 
 Multiple gestation (%) 
Maternal hypertension (%) 
Eclampsia/ pre-eclampsia (%) 
Maternal diabetes (%) 
Chorioamnionitis (%) 
Oligohydramnios (%) 
Corticosteroid (%) 
 

ix 
 
Table2: Comparison of Neonatal characteristics between delivery room group and 
control group : 
Parameters 
Delivery room  
CPAP group 
Control group 
P value 
Gestational age (wks.) 
 
Sex (male/female) 
 
Birth weight (gram) 
 
APGAR Score at 01 minute 
 
APGAR Score at 05 minute 
 
Mask ventilation in the delivery 
 
Intubation in the delivery room 
 
 
 
 
 
 

x 
 
Table 3: Comparison of primary outcomes  
Variable  
Delivery room CPAP 
Group n (%)  
Control Group n (%)  
 
P value  
 
Need for mechanical 
ventilation  
 
 
 
 
Need for surfactant  

 
 
 
Death within 7 days 
of hospital stay 
 
 
 
 
 
Table 4: Comparison of Secondary Outcomes 
Outcome 
Delivery room CPAP 
Group n (%) 
Control Group n (%)  
 
P value  
 
Frequency of apnea   
 
Days receiving CPAP 
 
Days receiving oxygen treatment 
 
Days until full enteral feeding  
 
Complications (%) 
Pneumothorax 
 
Intraventricular hemorrhage 
 
Necrotizing enterocolitis 
 
Patent ductus arteriosus 
 
 

xi 
 
APPENDIX I 
Data collection form 
Title: ‘Efficacy of delivery room continuous positive airway pressure in preterm 
neonates <34 weeks having respiratory distress: a single center randomized 
controlled clinical trial’. 
 
Principle investigator 
Dr. Nuzhat Nuary Jui 
Place of study 
 
Department of Neonatology, BSMMU, Shahbagh, Dhaka 
Date:  
ID no:      
A. Particulars of the patient: 
Registration no:               
Date of admission: 
Name of the newborn: 
Name of the mother:                                                         
Name of the father: 
Date of birth:                        
Postnatal age on admission (minutes): 
Address: 
 
Contact detail:   Mobile no. 
Land phone no. 
Email address: 

xii 
 
B. Maternal Information: 
Maternal age (years): 
Gestation:                                  
Single                    
Multiple 
Mode of Delivery 
Vaginal                      
LUCS 
Hypertension: 
Yes 
No 
If yes:                                                 
Duration (in months)   Medication  
Preeclampsia / Eclampsia:   
Yes 
No 
If yes: History of taking MgSO4 
Yes                          
No 
Oligohydramnios:                                     Yes                            
No 
Chorioamnionitis: 
Yes                            
No 
Placental abnormality: 
Yes 
No 
Pre-gestational Diabetes mellitus: 
Yes 
No 
Gestational Diabetes mellitus:  
Yes 
No 
If yes: Controlled with                        
Diet                          
Insulin  
                       
Antenatal Corticosteroid:  
Yes 
No 
  

xiii 
 
C. Neonatal Information: 
Gestational age (weeks): 
28-30                     31-32                      33- 34            
Sex:                                                  Male                                          Female 
Birth weight (gram):             
< 1200               1200-1500           
        > 1500 
Small for gestational age:  
Yes 
No 
 
Intra-uterine growth retardation: 
Yes 
No 
If yes:                                            
Symmetrical      
Asymmetrical 
APGAR score at 1 minute < 7:      
Yes 
No      
APGAR score at 5 minutes <7:  
Yes 
No 
D. Clinical parameters of the patient:     
Admitted to NICU: 
Yes                    
No   
Prolonged Capillary refill time:  
Yes       
No 
Tachycardia:              
Yes                        
No  
Bradycardia:                                
Yes                      
No 
Hypothermia:                             
Yes  
No 
Respiratory distress:         
Yes             
No 
Sepsis:                         
Yes        
No 
Seizure:  
Yes 
No 
 
 

xiv 
 
Duration of hospital stay:  
Hospital events:  
Need for mechanical ventilation:                                
Yes                      
No 
Need for surfactant:                                                     Yes  
                         No 
Death within 7 days of hospital stay:         
            Yes             
             No 
Frequency of apnea:                         
               Yes        
             No 
Days receiving CPAP:  
Days until full enteral feeding     
Complications: 
Pneumothorax:                                                                       Yes                                 No           
Intraventricular hemorrhage:                                      Yes                                 No 
Necrotizing enterocolitis :                                            Yes                                 No 
Patent ductus arteriosus :                                              Yes                               No 
Discharged on:  
  
 

xv 
 
APPENDIX Ⅱ 
Informed Written Consent 
Title: ‘Efficacy of delivery room bubble continuous positive airway pressure in 
preterm neonates <34 weeks having respiratory distress: a single center 
randomized controlled clinical trial’. 
Investigator’s name: Dr. Nuzhat Nuary Jui  
Institution/organization: Bangabandhu Sheikh Mujib Medical University. 
 
Purpose of this consent form is to inform you about necessary information that will 
help you for making decision to participate in this study. 
Purpose of the study: To evaluate the efficacy of delivery room  bubble continuous 
positive airway pressure (CPAP) in reducing  the  incidence of respiratory morbidity 
and mortality in preterm neonate during the hospital stay in early neonatal period.  
 
Procedure: After birth, preterm neonate less than 34 weeks will be assessed for 
respiratory distress. Baby who will be enrolled randomized by block randomization in 
two group, one group will get CPAP another group will be managed by supplemental 
O2. Both the group will transferred to NICU and managed accordingly by 
institutional protocol. Both group will be assessed for need for primary outcome 
mechanical ventilation, surfactant administration and death within 7 days and 
secondary outcome frequency of apnea, duration of CPAP, complication like 
pneumothorax, intraventricular hemorrhage. 
Risks: Baby will not be exposed to any physical risk. 
Right to withdraw: Your baby’s participation in this study is entirely voluntary. At 
any moment you can discontinue from the study, if you want.  
Cost: From this study you will not get any money and you have not to pay any. 
Privacy: Your privacy will be maintained during the process of data collection. 
Confidentiality of all gathered information will be maintained and will be used only 
for study purpose. Your personal information will not be disclosed to others. 

xvi 
 
Questions: If you have any question then please ask me. I will try to give answer. If 
you want to know anything in future then please contact with me by mobile phone 
(01718779874). 
Giving consent: I have understood that, participation of this study is entirely 
voluntary and at any time I have right to discontinue the study. 
 
I have read above information/above information has been read in front of me and I 
am agreed to enroll in your study.  
Thank you for your co-operation.   
 
 
………………………………………                                                   ………………………………… 
Signature of the investigator                                          Signature of the guardian 
 
 
 
 
 
 
 
 
 
 
 
 
 

xvii 
 
 
 
List of abbreviations: 
 
         BSMMU – Bangabandhu Sheikh Mujib Medical University 
         NICU – Neonatal intensive care unit   
         AGA – Appropriate for gestational age 
         SGA – Small for gestational age 
         LMP – Last menstrual period 
         IUGR – Intrauterine Growth Restriction 
         IRB – Institutional review board 
         USG – Ultra sonogram 
         CPAP- Continuous Positive Airway Pressure 
        bCPAP- Bubble Continuous Positive Airway Pressure 
 
 
 
 
 
 
 

xviii 
 
 
 
APPENDIX-Ⅳ 
References 
 Nahimana, SN 2015, ‘Bubble CPAP to support preterm infants in 
rural Rwanda: a retrospective cohort study’, BMC Pediatrics (2015) 15:135 
 
Blencowe, H, Cousens, S, Chou, D, Oestergaard, M, Say, L, Moller, AB, Kinney, M 
& Lawn, J 2013, ‘Born Too Soon: The global epidemiology of 15 million 
preterm births’, Reproductive Health, vol. 10, no. SUPPL. 1, pp. 1–14. 
 
W.A. Gonc¸ alves-Ferri, F.E. Martinez, J.P.S. Caldas, S.T.M. Marba, S. Fekete, L. 
Rugolo, C. Tanuri, C. Leone, G.A. Sancho J 2013, Application of continuous positive 
airway pressure in the delivery room: a multicenter randomized clinical trial’, 
Brazilian Journal of Medical and Biological Research (2014) 47(3): 259-264, 
 
 
 Saumil Ashvinkumar Desai, Pankaj Tule, Ruchi Nimish Nanavati,  2017,  
 Labour room Continuous Positive Airway Pressure (LR CPAP) in preterm neonates 
<34 weeks: An Indian experience,'  SUDANESE JOURNAL OF PAEDIATRICS ; Vol 17, 
Issue No. 2  
 
Charpak, N, Montealegre-Pomar, A & Bohorquez, A 2022, Delivery room CPAP in 
improving outcomes of preterm neonates in low-and middle-income countries: A 
systematic review and network meta-analysis, europian R E S U S C I T A T I O N  
counsil 1 7 0 ( 2 0 2 2 ) 2 5 0 –2 6 3 
 
 
Heather Weydig, Noorjahan Ali, Venkatakrishna Kakkilaya, 2019, ‘Noninvasive 
Ventilation in the Delivery Room for the Preterm, , vol. 47, no. 3, pp. 1–8. 

xix 
 
International Journal of Paediatrics. 
 
Neil N. Finer, MD; Waldemar A. Carlo, MD; Shahnaz Duara, MD; 2016, ‘Delivery 
Room Continuous Positive Airway Pressure/Positive End-Expiratory Pressure in 
Extremely Low Birth Weight Infants: A Feasibility Trial’, PEDIATRICS Vol. 114 No. 3 
  
Colin J. Morley, M.D., Peter G. Davis, M.D., Lex W. Doyle, A 2021, ‘Nasal CPAP or 
Intubation at Birthfor Very Preterm Infants, Nasal CPAP or Intubation at Birth for 
Very Preterm Infants3, pp. 216–224. 
 
Ho_JJ, Subramaniam , P. Davis.2020, ‘Continuous positive airway pressure (CPAP) for 
respiratory distress in preterm infants’, Cochrane Database of Systematic Reviews 
DOI: 10.1002/14651858 no. 4, pp. 194–200. 
 
Bahareh Bahman-Bijari; Arash Malekiyan, Pedram Niknafs, Mohammad-Reza 
Baneshi2. 2011, Bubble– CPAP vs. Ventilatory– CPAP in Preterm Infants with  
Respiratory Distress, Iranian Journal of Pediatrics ; Vol 21 (No 2), Pp: 151-158 
 
JAGDISH KOTI, SRINIVAS MURKI, PRAMOD GADDAM, ANUPAMA REDDY, M 
DASARADHA RAMI REDDY . 2010. Bubble CPAP for Respiratory Distress Syndrome in 
Preterm Infants, Indian pediatrics. Vol 47 Pages 129-130 
 
Tufail Soomro , Shiyam Sunder Tikmani , 2016. Success of Bubble CPAP in Treatment 
of Respiratory Distress Syndrome in Preterm Infants, Journal of General Practice, Vol 
Volume 4 , Issue 4 , Page 1-4. 
 
Beena D. Kamath,  Emily R. MacGuire,  Elizabeth M. McClure, Robert L. Goldenberg, 
Alan H. Jobe, 2011, Neonatal Mortality From Respiratory Distress Syndrome: Lessons 
for Low-Resource Countries, Pediatrics, Vol 127, Page 1139–1146 
 
 

xx 
 
Teresa Nowadzky, Alfonso Pantoja, John R. Britton, 2009, Bubble Continuous Positive 
Airway Pressure, A Potentially Better Practice, Reduces the Use of Mechanical 
Ventilation Among Very Low Birth Weight Infants With Respiratory Distress 
Syndrome, Pediatrics, Vol 123, Page 1535–1541 
 
Kawaza K, Machen HE, Brown J, Mwanza Z, Iniguez S, et al. (2014) , efficacy of a low-
cost bubble CPAP system in the treatment of respiratory distress in a neonatal ward 
in Malawi. PLoS One, Vol 29: 863 -868 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                        APPENDIX-V 
  
Timetable of the study: 

xxi 
 
 
 
1 month 
1 month 
13 months 2 months 
1 month 
Article review and 
Topic selection 
 
 
 
 
 
IRB clearance 
 
 
 
 
 
Data collection 
 
 
 
 
 
Follow up 
 
 
 
 
 
Data analysis Report 
writing 
 
 
 
 
 
 
 
 
APPENDIX-VI 
Budget 
Books and literatures 
25,000 Taka 
Pulse oximetry  
20,000 Taka 
Usg of brain 
              500×51=25,500 
Chest X ray 
            1200×51= 61,200 
Echocardiogram 
             2000 × 51=102,000 
Septic screen 
Blood culture sensitivity 
 
              580 x 66 = 38,280 Taka 
800 x 66 = 52,800 Taka 
                

xxii 
 
Data analysis 
25,000 Taka 
Printing 
25,000 Taka 
 
 
 
 
Total 
                282,980  
Funding source: Self