Comparing Intubation Rates in the Delivery Room by Interface
Conditions: Ventilator Lung; Newborn
Sponsor: University of Illinois College of Medicine at Peoria

 
 
  
 
 
Questions? Contact Kelsey Balcer, BS, CCRP, (309) 655-2189 or kbalcer@uic.edu. 
 
  
 
 
 
 
Comparing Intubation rates in the delivery room by interface  
 
 
NCT05609773 
 
July 19, 2022 
 

 
 
  
 
 
Questions? Contact Kelsey Balcer, BS, CCRP, (309) 655-2189 or kbalcer@uic.edu. 
 
  
 
 
Research Proposal 
Department of Pediatrics 
Project Title: Comparing intubation rates in the delivery room by interface 
7-19-2022 
 
Study Personnel: 
 
Name, degree 
Role 
Employer 
Ashley Fischer, MD 
Co-PI 
UICOMP 
Gretchen Kopec, MD 
Co-PI 
UICOMP 
M. Jawad Javed, MD 
Investigator 
UICOMP 
Praveen Kumar, MD 
Mentor 
UICOMP 
Kamlesh Macwan, MD 
Collaborator 
UICOMP 
 
 
 
 
Study Sites: 
x OSF - St. Francis Medical Center - Peoria     
☐ St. Jude Midwest Affiliate 
☐ Unity Point Methodist/Proctor    
☐ UICOMP 
☐ Other:  
 
Anticipated study duration after start: 1 year 
 
Needed services: 
x Statistician 
☐ Healthcare Analytics 
 
 
Funding source: 
☐The research specified in this protocol will not be funded. 
☐The research specified in this protocol is funded by a pharmaceutical/device company. 
☐The research specified in this protocol is funded through NIH 

 
 
  
 
 
Questions? Contact Kelsey Balcer, BS, CCRP, (309) 655-2189 or kbalcer@uic.edu. 
 
  
X Other: applying for department and CHOI grant funding 
 
x This study has been reviewed with the relevant division(s) or division head(s). 
☐ I request detailed feedback/mentorship from the Research Facilitation Committee for 
this project. 
 
 

 
 
  
 
 
Questions? Contact Kelsey Balcer, BS, CCRP, (309) 655-2189 or kbalcer@uic.edu. 
 
  
Background and rationale 
Although the majority of premature neonates < 30 weeks gestion require positive 
pressure ventilation (PPV) at birth, the optimal interface to provide PPV has not 
been determined. Preferably this support would be provided by non-invasive means 
to prevent the development of bronchopulmonary dysplasia. Resuscitation with a 
face mask, single nasal tube, nasal prongs, and/or LMA are all approved methods 
of resuscitation per NRP as of 2010. Face masks have been associated with more 
dead space, air leak and airway obstruction however are the most commonly used 
interface. Recently, the Trigeminal Cardiac Reflex has been described, which can 
be induced with the placement of a facemask, resulting in bradycardia and apnea. 
Bi-nasal prongs (RAM cannula) have been found in studies to be associated with 
lower intubation rates in the delivery room (down to 24 weeks gestation), less need 
for epinephrine, chest compressions, and subsequent invasive ventilation. In 
addition to the potential practical advantages of bi-nasal prong resuscitation, there 
is evidence to suggest that ventilation through the nose may stimulate the 
subepithelial receptors of the upper airways causing an increase in respiratory rate 
and depth.  
Both binasal prongs and face masks are acceptable by NRP and have been 
utilized for neonatal resuscitation at OSF SFMC since 2016, however the choice is 
by provider preference with rare use of the bi-nasal prongs. Also, historically we 
have provided constant positive airway pressure (CPAP) during delayed cord 
clamping with a facemask by the OB team who needs to remain sterile during a C/S 
(majority of premature deliveries). Thus, nearly all babies have had some exposure 
to a facemask during the initial resuscitation period.  
For our prospective study we will sterilize facemasks, bi-nasal prongs, and tubing. 
A neonatal provider will scrub and don sterile gown and gloves to be able to provide 
the infant with the CPAP utilizing the study interface during delayed cord clamping. 
That same interface will be continued during resuscitation measures after delayed 
cord clamping is complete. 
The interface utilized in the delivery room to provide resuscitation has been 
recorded in the Vermont Oxford Database since 2018. On retrospective review of 
patients born < 30 weeks’ gestation, 7/30 of neonates resuscitated with bi-nasal 
prongs were intubated in the delivery room (23%) and 114/136 of neonates 
resuscitated with facemask were intubated in the delivery room (84%). There were 
33 infants in which both a facemask and bi-nasal prongs were utilized during initial 
resuscitation as well, 13 of required intubation (39%). However, we are unable to 
determine from the database which interface was utilized first. Also, prior to 2021, 
only one neonatologist was utilizing bi-nasal prongs thus it is difficult to determine if 
the difference is entirely due to the interface alone. 
 
 
 
 

 
 
  
 
 
Questions? Contact Kelsey Balcer, BS, CCRP, (309) 655-2189 or kbalcer@uic.edu. 
 
  
Specific Aims/Objectives  
We hypothesize that there will be at least a 40% reduction in the rate of intubation 
for patients born < 30 weeks’ gestation when bi-nasal prongs are utilized for 
neonatal resuscitation vs face mask. 
 
Research Design and Methods 
1. Subject population  
Subject identification/recruitment: 
All patients born at OSF SFMC < 30 weeks’ gestation  
 
Inclusion/exclusion criteria, including age: 
Inclusion: all resuscitated infants < 30 weeks’ gestation born at OSF SFMC  
Exclusion: diagnosis of congenital diaphragmatic hernia, no PPV needed, or no 
resuscitation desired due to major congenital anomalies or peri-viable status 
 
Estimated sample size: 
Hypothesis: 40% reduction in intubations in the delivery room 
Baseline intubation rate for facemask resuscitation in neonates < 30 weeks from 
2018-2020: ~80% (retrospective intubation rate for ram cannula resuscitation 23%) 
alpha 0.05, beta 80% 
Estimated sample size = 42 patients 
 
Estimated M:F ratio: 
1:1 
 
2. Study design (specify study type, any randomization or control groups) 
Prospective stratified randomization with separate blocks for neonates with a 
gestational age < 25 0/7 weeks and those 25 1/7 weeks to 29 6/7 weeks gestation. 
 
3. Procedures (step by step description of each part of the study, tools to be used, any 
subject compensation) 

 
 
  
 
 
Questions? Contact Kelsey Balcer, BS, CCRP, (309) 655-2189 or kbalcer@uic.edu. 
 
  
1) Consent would be obtained prior to birth by neonatologist 
2) Randomization would occur prior to delivery 
3) Patients receiving non-randomized apparatus will be considered a protocol 
violation. 
4) CPAP will be set up prior to either c/s or vaginal delivery utilizing either an 
appropriately sized face mask or ram cannula. Sterile packets with tubing and 
prongs or a facemask will be supplied for C/S. 
a) Bi-nasal prong Resuscitation 
i) 
Settings on T-piece are set to PIP of 22, PEEP of 6, Flow of 10 L, 
FiO2 30%. (Settings are slightly higher than facemask to account 
for known leak with RAM cannula so the pressure seen by the 
lungs should be equivalent between the nasal prongs and 
facemask.) 
ii) 
Immediately after delivery, place the RAM cannula in correct 
position with the prongs in the nares (prongs should face down into 
the nasopharynx) and tighten the strap around the head. 
iii) 
If the neonate is actively breathing, provide CPAP via the RAM 
cannula and T piece 
iv) 
If the neonate is apneic or ineffectively breathing, provide PPV via 
the RAM cannula and T piece at a rate of 40-60 breaths per minute 
by holding the cannula with your thumb and closing the mouth with 
your middle finger to ensure a proper seal 
v) 
If the heart rate starts to increase, continue with resuscitation per 
NRP guidelines 
vi) 
If the heart rate does not increase appropriately, troubleshoot the 
RAM cannula: 
(1) Suction nares and mouth 
(2) Maintain Closed mouth 
(3) Adjust RAM Cannula in nose to ensure seal 
(4) Reposition head and neck to open airway 
(5) Increase pressure by increments of 2 until adequate chest 
rise is seen or at a PIP of 30 
(6) Alternative Airway (intubation) 
vii) 
When 60 seconds of delayed cord clamping is complete (if 
appropriate to perform delayed cord clamping) - Patient will move 
on the bed to the resuscitation room to complete resuscitation as 
above. Pulse oximeter to be placed on the right wrist and EKG 
leads placed in the appropriate position.  
a. Face mask resuscitation 
i. 
Settings on T-piece are set to PIP of 20, PEEP of 5, Flow of 10 L, 
FiO2 30%. 
ii. 
After delivery, place the face mask in the correct position on the 
face, bringing the chin to the mask 

 
 
  
 
 
Questions? Contact Kelsey Balcer, BS, CCRP, (309) 655-2189 or kbalcer@uic.edu. 
 
  
iii. 
If the neonate is actively breathing, provide CPAP via the Face 
Mask and T piece 
iv. 
If the neonate is apneic or ineffectively breathing, provide PPV via 
the Face Mask and T piece at a rate of 40-60 breaths per minute 
v. 
If the heart rate starts to increase, continue with resuscitation per 
NRP guidelines 
vi. 
If the heart rate does not increase appropriately, troubleshoot the 
Face Mask: 
1. Adjust the Face Mask 
2. Reposition the head and neck to open airway 
3. Suction mouth, then nares 
4. Open Mouth 
5. Increase pressure by increments of 2 until adequate chest 
rise is seen or at a PIP of 30 
6. Alternative airway (intubation) 
vii. 
When 60 seconds of delayed cord clamping is complete (if 
appropriate to perform delayed cord clamping) - Patient will move 
on the bed to the resuscitation room to complete resuscitation as 
above. Pulse oximeter to be placed on the right wrist and EKG 
leads placed in the appropriate position.  
 
4. Statistical Analysis Plan (sample size, power justification, specific tests to 
compare variables) 
Primary objective: 40% reduction in intubation rate from resuscitation with facemask 
vs binasal prongs.  
Secondary objectives: incidence of chest compressions and epinephrine in the 
delivery room, incidence of chronic lung disease, mortality, severe IVH (grade 3-4), 
severe ROP (stage 3-5) - all would be compared with chi-square testing. Would also 
analyze average hematocrit and base deficit (if a blood gas is obtained) after 
admission to the NICU and compare groups via student t-test. 
 
5. Consent procedures (if applicable, or rationale for waiver of consent; list study 
personnel responsible for consent) 
Parents would be consented prior to birth. If parents do not consent for inclusion in 
the study, the neonate would be resuscitated per routine by NRP guidelines utilizing 
the interface of provider preference. 
 
6. Risks to subjects/Minimization of Risks (including alternatives to treatment, and 

 
 
  
 
 
Questions? Contact Kelsey Balcer, BS, CCRP, (309) 655-2189 or kbalcer@uic.edu. 
 
  
any benefits to participation) 
Patients would have minimal risk. Both interfaces are acceptable for use by NRP. 
Thus, only risk would be in regards to the storage of patient information. 
 
7. Measurement   
Data to be collected: 
See excel spreadsheet attached 
 
List any additional data elements that will need to be accessed for the study, but not 
collected (eg when selecting patients from the EMR): None 
 
If specimens/sample will be obtained, described how they will be labelled including 
any patient identifiers: N/A 
 
8. Data Storage Plan (where/how will data be stored, accessed, and protected; 
paper records vs Excel/REDCap) 
Data will be stored on REDCap 
 
Duration of data storage after study completion: 3 years 
 
Plan for deletion of data or removal of identifiers: Patient ID will be removed once all 
data is collected and finalized 
 
9. Alignment (How does this project align with or add value to department/institutional 
objectives?) 
The project is well aligned with multiple division goals - reducing intubation rates in 
the delivery room has the potential of avoiding CPR, allowing for LISA administration 
which has been associated with lower rates of severe IVH and chronic lung disease 
than other modes of surfactant administration. The project would also contribute 
significantly to the literature regarding the optimal interface device in the delivery 
room. 
 
10. Goals for Publication/Presentation of Results (include plans for authorship, 
guidelines can be found here) 
Will plan to publish results and present at conferences such as PAS and AAP. 

 
 
  
 
 
Questions? Contact Kelsey Balcer, BS, CCRP, (309) 655-2189 or kbalcer@uic.edu. 
 
  
 
References 
Aziz, Khalid, et al. “Part 5: Neonatal Resuscitation 2020 American Heart Association 
Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.” 
Pediatrics, vol. 147, no. Supplement 1, 2020, doi:10.1542/peds.2020-038505e.  
Biniwale, Manoj, and Fiona Wertheimer. “Decrease in Delivery Room Intubation Rates 
after Use of Nasal Intermittent Positive Pressure Ventilation in the Delivery Room for 
Resuscitation of Very Low Birth Weight Infants.” Resuscitation, vol. 116, 2017, pp. 33–
38., doi:10.1016/j.resuscitation.2017.05.004.  
Capasso, Letizia, et al. “A Randomized Trial Comparing Oxygen Delivery on 
Intermittent Positive Pressure with Nasal Cannulae versus Facial Mask in Neonatal 
Primary Resuscitation.” Acta Paediatrica, vol. 94, no. 2, 2007, pp. 197–200., 
doi:10.1111/j.1651-2227.2005.tb01890.x.  
Gaertner, Vincent D, et al. “Physiological Responses to Facemask Application in 
Newborns Immediately after Birth.” Archives of Disease in Childhood - Fetal and 
Neonatal Edition, 2020, doi:10.1136/archdischild-2020-320198.  
“Kattwinkel, Et Al. Special Report: Neonatal Resuscitation: 2010 American Heart 
Association Guidelines for Cardiopulmonary Resuscitation and Emergency 
Cardiovascular Care. Pediatrics. 2010;126(5):e1400-e1413.” PEDIATRICS, vol. 128, no. 
1, 2011, pp. 176–176., doi:10.1542/peds.2011-1260.  
Kuypers, Kristel L.A.M., et al. “The Effect of a Face Mask for Respiratory Support on 
Breathing in Preterm Infants at Birth.” Resuscitation, vol. 144, 2019, pp. 178–184., 
doi:10.1016/j.resuscitation.2019.08.043.  

 
 
  
 
 
Questions? Contact Kelsey Balcer, BS, CCRP, (309) 655-2189 or kbalcer@uic.edu. 
 
  
Machumpurath, Smitha, et al. “Interfaces for Non-Invasive Neonatal Resuscitation in the 
Delivery Room: A Systematic Review and Meta-Analysis.” Resuscitation, vol. 156, 
2020, pp. 244–250., doi:10.1016/j.resuscitation.2020.08.008.  
McCarthy, Lisa K, et al. “Nasal Airways (Single or Double Prong, Long or Short) for 
Neonatal Resuscitation.” Cochrane Database of Systematic Reviews, 2011, 
doi:10.1002/14651858.cd009102.  
Schmolzer, G. M., et al. “Airway Obstruction and Gas Leak during Mask Ventilation of 
Preterm Infants in the Delivery Room.” Archives of Disease in Childhood - Fetal and 
Neonatal Edition, vol. 96, no. 4, 2010, doi:10.1136/adc.2010.191171.