The Effect of Modified Supporting Play, Exploration and Early Development on Motor Performance in Bhutanese Preterm Infants- Randomized Controlled Trial
Phase: NA
Conditions: Infant, Premature
Sponsor: JDWNRH

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THE EFFECT OF MODIFIED SUPPORTING PLAY, EXPLORATION AND EARLY 
DEVELOPMENT INTERVENTION ON MOTOR PERFORMANCE IN 
BHUTANESE PRETERM INFANTS- RANDOMIZED CONTROLLED TRIAL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Investigators and institutions 
Karma Lhaki1, 2, Raweewan Lekskulchai2, Stacey Dusing3, Sureelak Sutchritpongsa4 
1Department of Physiotherapy, Jigme Dorji Wangchuck National Referral Hospital, Thimphu 
Bhutan 
2Faculty of Physical Therapy, Mahidol University, Thailand 
3Division of Biokinesiology and Physical Therapy, University of Southern California  
4Faculty of Medicine, Siriraj Hospital, Mahidol University, Thailand 
 
Abstract  
Advancement of medical services has improved the survival of preterm infants but they 
are at high risk of neurodevelopmental impairments. There is growing evidence suggesting that 
early intervention is more effective in improving developmental outcomes in preterm infants 
but developmental services are limited and usually started very late in developing countries. 
Knowledge regarding effect of physical therapy intervention from resource limited settings is 
sparse and physical therapy has come under criticism for not evaluating and providing 
evidence-based interventions in infants born preterm. Objective of this study is to investigate 
the efficacy of customized physical therapy intervention on motor performance in preterm 
infants by conducting a randomized controlled trial where infants born preterm will be 
randomized into intervention and standard care group. 28 preterm infants shall be recruited for 
the study and followed up till 3 months of corrected age. Test for infant motor performance 
(TIMP) and Rapid neurodevelopmental assessment (RNDA) will be administered at baseline, 
1 month, 2 months and 3 months of corrected age. The physical therapy intervention which 
includes supporting play exploration and early development intervention (SPEEDI) adapted 
for Bhutanese culture and setting will be provided post discharge from the hospital. A two- 
way mixed model ANOVA will be performed to investigate the motor performance and 
neurodevelopment of preterm infants and the significance level will be set at p-value <0.05. 
This study will be reported as the effectiveness of physical therapy intervention on motor 
performance in preterm infant. 
 
 
 

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KEY WORDS: PRETERM, NEURODEVELOPMENTAL IMPAIRMENTS, MOTOR 
PERFORMANCE, TEST FOR INFANT MOTOR PERFORMANCE, RAPID 
NEURODEVELOPMENTAL IMPAIRMENT, PHYSICAL THERAPY INTERVENTION, 
SPEEDI 
 
 
 
1.1 Introduction  
 
             Globally around 15 million infants are born premature (<37 weeks gestation) annually 
which accounts to more than 1 in 10 live births and it’s a leading cause of neonatal mortality 
and morbidity(1, 2). Most common complications of preterm birth are respiratory distress 
syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, sepsis, periventricular 
leukomalacia, seizures, intraventricular hemorrhage, feeding difficulties, hypoxic ischemic 
encephalopathy, and visual and hearing problems(3-6). However, advances in neonatal 
intensive care has improved the survival of sick and vulnerable newborns, particularly infants 
born preterm but the rate of disability has relatively remained constant, with up to 50% of these 
infants later exhibiting developmental disabilities such as motor, cognitive or behavioral 
impairments(4, 6-11).These developmental disabilities  are complex, diverse and impact 
multiple domains which restricts participation in home, at school and in community which 
ultimately affect the overall quality of life of the child and the family(12). 
                    The effects of premature birth are not only experienced by the infants but also by 
the parents. The parents commonly experience helplessness, fear, loss and inadequacy(13, 14). 
Over the course of hospitalization parents feel increased stress, anxiety and depression(15, 16). 
Some parents also demonstrate symptoms of post-traumatic stress disorder(17). The emotional 
stress on parents of the infants born preterm can lead to disruptive interactive pattern with their 
infants which may have long term adverse effect on attachment pattern, affective state 
regulation, social interaction and overall developmental outcomes on the infant(18). Therefore, 
families of infants born preterm  often experience immense psychological stress and financial 
burden due to prolonged stay and the infant requiring repeated admission in the hospital which 
further leads to significant cost to health system(19-21).  
           The preterm period is very crucial period in terms of high risk for injury to the brain as 
well as sensitive time frame for motor development (22). According to the dynamic system 
theory, motor development is believed to be a feedback process based on interaction among 

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different subsystems in the child, the environment and the task. Studies have established that 
motor and cognitive development go hand in hand such that delay in one domain can contribute 
to delay in another domain(23, 24). Typically developing infants uses movement to 
communicate and learn about the object by interacting physically with the environment 
allowing  the development of other developmental domains besides motor, especially cognition 
which is usually impaired in children born preterm(25, 26). Postural control is the pre-requisite 
for development of motor skills which is usually impaired in infant born preterm which is later 
associated with motor impairments persisting throughout childhood(27, 28).  
                  As infant’s brain is highly plastic, interventions which focusses on enhancement of 
parent-child interaction, adaptation of environment to promote motor, social or cognitive 
development and parent education to promote developmental skill in the infant has been found 
effective (29-32). Numerous studies also focuses on interventions which  involves active 
participation from the infants as it leads to structural and functional changes in the brain infant 
born preterm to promote neuroplasticity and as it is more likely to have maximum impact on 
the motor development of infant born preterm(33, 34). Since preterm period is considered 
sensitive time frame for motor development, intervention focused on motor skills might be 
beneficial for motor development in infants born preterm.  
            With the advancement of medical services the survival of preterm infants has improved 
but the developmental services to these vulnerable population continues to be “wait and watch” 
approach and they miss out on the critical period to start early intervention (35). There is 
growing  evidence suggesting that early intervention is more effective in improving 
developmental outcomes in preterm infants compared to interventions which are started later 
in life(36-40). But most of these published studies on early interventions are laborious, time 
consuming and resource intensive limiting its use on a large scale particularly in some medical 
resource limited settings and are applicable in high income countries. Since there is a growing 
emphasis on evidence-based practice, physical therapy has come under criticism for not 
evaluating and providing evidence based interventions in infants born preterm (41) and as there 
is limited study on the effect of early physical therapy intervention (38), there is a need to study 
the effect of physical therapy intervention provided in a resource limited medical settings to 
improve the developmental outcome in infant born preterm.  
                      With the launch of Every Newborn Action Plan at the sixty-seventh World Health 
Assembly in 2014, the focus of care has shifted from mere survival of newborns to thriving 
well especially among vulnerable small and sick newborns. The Nurturing Care Framework 
for Early Childhood Development, launched by WHO, UNICEF and the World Bank Group, 

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demonstrates that focusing on early childhood development is one of the wisest investments a 
country can make to boost economic growth. Therefore, there is a need of efficacious early 
intervention with clear evidence to optimize outcomes in preterm infants so that the preterm 
infants and families benefit in the long run.  
                At Jigme Dorji Wangchuck National Referral Hospital (JDWNRH), Thimphu 
Bhutan the prevalence of preterm birth was 6.4% (64 per 1000 live birth)(42). This study will 
be conducted at JDWNRH which is a tertiary care hospital with NICU facility. The participants 
for the study will be low risk preterm infants since these group of infants are followed up 
periodically to monitor for developmental outcome, the follow up starts only when the child 
attends 3 months of corrected age and they miss out on the critical period to start intervention. 
In Bhutan, due to a shortage of pediatric physical therapists (PT), this group of infants does not 
receive proper attention and if the parents are taught how to provide a home programme, it 
helps in empowering the parents and reducing the burden and stress of bringing the child for 
therapy at the clinic regularly. This will also help the limited number of PTs in the country to 
provide better care and support to the high-risk preterm infants.  
                   Most of the early intervention programs are resource intensive and requires a multi-
disciplinary team. In a setting where there is limited human resources, customized physical 
therapy intervention will empower parents to provide intervention to their infant within the 
natural environment of their home with no extra resources required. Involving parents as 
primary practitioners will help them to understand and respond more knowledgably to their 
infant’s behaviour, which can promote optimal development. Therefore, the long-term 
outcome of this study is to provide appropriate physical therapy intervention to infants born 
preterm post discharge from the neonatal unit so that it can improve the motor development 
and prevent the neurodevelopmental impairments. The findings from this study will help in 
providing appropriate physical therapy intervention which involves parent, therapist and infant 
interactions to enhance the motor development of infants born preterm.  
 
 
 
 
 
 
 
 

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1.2 Conceptual framework 
 
 
 
Figure 1: Conceptual framework 
 
 
 
 
 
 
 

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1.3 Objectives  
 To investigate the effect of modified supporting play, exploration and early development        
(SPEEDI) on neuromotor performance in infants born preterm when the intervention is 
provided by the parents post discharge from Neonate Intensive Care Unit (NICU) compared 
to infants born preterm receiving standard care at 3 months of corrected age 
1.3.1 Specific objective  
1. To compare the difference in motor performance between infants born preterm receiving 
modified supporting play, exploration and early development intervention (SPEEDI) and 
standard care at baseline, 1 month, 2 months and 3 months of corrected age. 
2. To compare the difference in neurodevelopment between infants born preterm receiving 
modified supporting play, exploration and early development (SPEEDI) and standard 
care at baseline, 1 month, 2 months and 3 months of corrected age 
3. To compare the compliance of parents with infants born preterm receiving modified 
supporting play, exploration and early development intervention (SPEEDI) and standard 
care. 
1.4 Study design  
         The proposed study will be single-center, prospective, double-blinded randomized 
controlled trial (RCT) to study the effect of physical therapy intervention on motor 
performance of infant born preterm. 
 
1.4.1 Study setting  
         All data collection will be performed at Pediatric Physiotherapy Unit, Jigme Dorji 
Wangchuck National Referral Hospital (JDWNRH), Thimphu Bhutan. 
 
1.4.2 Participants  
          During the study period infants born preterm (<37 weeks) at Neonatal Intensive Care 
Unit (NICU) of Jigme Dorji Wangchuck National Referral Hospital (JDWNRH), Thimphu 
Bhutan meeting the following inclusion and exclusion criteria shall be recruited for the study.  
 

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1.4.3 Inclusion criteria 
• Infants who are born <37 weeks’ gestation 
• Medically stable and off ventilator on discharge from NICU 
• Parents who consent to come for follow up.  
 
  
1.4.4 Exclusion criteria  
        Infants will be excluded from the study if they have  
• Cortical blindness or retinopathy of prematurity causing blindness 
• Musculoskeletal/congenital abnormalities 
• Brain injuries including intraventricular hemorrhage (grade 3 and above), hypoxic 
ischemic encephalopathy and hydrocephalus 
• Genetic syndrome 
• Infants undergone major surgery  
• Family who do not consent  
• Parent with physical and psychological problems 
• Infants with medical devices such as NG tube and gastrostomy  
 
 
1.4.5 Sample size 
          Sample size calculation will be based on the study by Dusing et al(43). According to 
the study they found a significant difference in motor performance of infants born preterm 
who received physical therapist delivered intervention compared to the usual care group. The 
effect size from the study was Cohen’s d of 1.29 for TIMP z- score. Using this data, the total 
sample size of 22 was obtained using G power program version3.1. However, with 20% drop 
out rate a total of 28 infants born preterm would be required with 14 in each group.  

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Figure 2: G power 
1.4.6 Variables  
Independent variable  
1. Groups: Intervention group and standard care group 
2. Time: At baseline, 1, 2 and 3 months of corrected age 
  
Dependent variable  
1. Motor performance  
2. Neurodevelopment 
3. Compliance  
 
1.4.7 Data Collection  
                The study will be conducted after seeking ethical approval from Institutional 
Review Board (IRB), Khesar Gyalpo University of Medical Sciences of Bhutan (KGUMBS). 
The data will be collected at pediatric physiotherapy unit, JDWNRH. Preterm infants referred 
for high risk follow up clinic at Pediatric Physiotherapy Unit that evaluates 
neurodevelopmental outcome will be recruited. Oral and written information will be given to 
parents of the preterm babies fulfilling the inclusion criteria. Parents will be informed 
regarding the objectives, procedures, risk and benefits of the study. Informed consent will be 
taken from the parents prior to the study by the principal investigator. Strategies to achieve 
adequate participant enrolment to reach target sample size will be, establish a link between 

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the research team and mother and father of each of the subjects included, regardless of the 
group allocated since randomization.              
                Randomization will be performed by blindly drawing the slip from the container which will 
have equal numbers of same size and shape slips and will be performed by the research assistant 
who will not be responsible for any intervention nor outcome assessment. After randomization 
the infants in the control group will receive standard care and the infants in the intervention 
group will receive modified SPEEDI. The principal researcher will provide the modified 
SPEEDI. The research assistants shall be physical therapist or physical therapy assistants and 
occupational therapist who has over 2 years of experience in working with pediatric population 
and will be blinded to the group allocation since they will assess the outcome. These research 
assistants will be trained to use the measurement tools by the principal researcher. As the study 
participants are preterm infants, caution will be taken to avoid thermal stress to these infants by 
keeping the data collection room in pediatric physiotherapy unit warm.  During the study process 
if there are amendments to the study protocol, the information shall be communicated with the 
IRB and the co-investigators of the study.  
                     
1.4.8 Measurement 
          Prior to the assessment of motor performance and neurodevelopment, demographic 
details such as gestational age, length of stay in the hospital and medical diagnosis will be 
recorded. The measurement will be taken at 40 weeks of post menstrual age, 1 month, 2 months 
and 3 months of corrected age by the research assistants who will be blinded to group 
assignment.   
 
      
1.4.8.1 Motor performance  
             Motor performance will be assessed using The Test of Infant Motor Performance 
(TIMP) version 5.1, administered when the child is awake (Brazelton state 3,4 or 5). The infant 
should wear minimal clothing as possible. Testing will be performed on a firm surface with no 
distractions. No more than 3 trials will be allowed for each elicited item. If the infant gets fussy 
and irritable during the process of assessment, breaks can be taken in between the assessment 
and if the parents are not comfortable with the procedure the parents will have every right to 
withdraw and discontinue their infant’s participation from the study. However, if the parent 
consents to continue the assessment, items that remain during the first session shall be 

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completed in second session within 24 hours so that it assessor does not have to redo the whole 
assessment again. 
               The Test of Infant Motor Performance (TIMP) was developed to assess functional motor 
performance in infants from 34 weeks postmenstrual age (PMA) through 4 months corrected 
age. The TIMP is a 42- item assessment with 13 dichotomous items scored based on 
observation of spontaneous movement and 29 elicited items with 4 to 7-point rating scales 
based on handling of the infant in a variety of positions in space. The test takes 20-35 min to 
administer and score with variation based on age and tolerance of the infant and the experience 
of the tester. It has been described as one of the best tools to discriminate between age-
appropriate and delayed motor performance in preterm and term infants, and to predict later 
motor development. The TIMP is a valid and reliable tool developed to detect typical and 
atypical performance in preterm infants and evaluate the effect of an intervention on the infant 
motor performance(44-46). The assessment tool has been also used in multiple clinical trials 
to evaluate the effectiveness of therapy intervention. 
 
  
1.4.8.2. Neurodevelopment  
         Neurodevelopment will be assessed using the Rapid Neurodevelopmental Assessment 
(RNDA), administered when the child is awake and there should be no distraction and 
prompting allowed from parents while performing the assessment. While administering the 
assessment the response elicited from the infant will be recorded.  
         The Rapid Neurodevelopmental Assessment (RNDA) tool is a reliable and valid 
developmental assessment tool for use by multidisciplinary professionals in developing 
               country to assess the neurodevelopmental status of children from 0-24 months(47). The tool 
has been a useful to identify neurodevelopmental impairment (NDI) in resource limited settings 
where there is lack of trained professionals to identify children with neurodevelopmental 
impairments. It assesses developmental domains such as primitive reflexes (0 to <1 month), 
gross motor, fine motor, vision, hearing, speech, cognition, behavior and seizures. It helps to 
identify impairments in these developmental domains and categorizes into three degrees of 
impairments which are mild, moderate and severe impairment. 
 
1.4.8.3. Compliance  
Parent compliance will be measured by the ability of the parent to correctly demonstrate 
the home program activity when they come for the follow up visit. In addition, parental 
compliance will be measured by quantifying the amount of time spent with the infant 

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performing the intervention at home, number of intervention sessions attended, the number of 
enrolment and outcome assessment at the end of the study.   
 
 
 
Figure 3: Procedure 
 
 
 
 
 
 
 
 
 
Enrollment 
Assess for 
eligibility 
Intervention group(Intervention provided 
by principal researcher )  
Standard care group( Intervention 
provided by research assistants) 
Assessment at 2 months of corrected age: TIMP & RNDA ( By research 
assistants) 
Baseline assessment(40 weeks): 
TIMP & RNDA 
Informed consent 
Assessment at 3 months of corrected age: TIMP & RNDA ( By research 
assistants) 
Assessment at 1 month of corrected age: TIMP & RNDA ( By research 
assistants)  
Randomization 

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1.4.8.4 Intervention  
Intervention group  
                              The intervention that will be used for this study will be adapted and modified for 
the Bhutanese cultural context, from supporting play exploration and early development 
intervention (SPEEDI) (43). The intervention is designed to improve the developmental 
outcome of preterm infants who are at risk of developmental disabilities. SPEEDI uses the 
combined therapist and parent delivered intervention to increase opportunities for 
developmentally appropriate social, cognitive and motor play without excessive parental and 
financial burden. SPEEDI blends the synactive theory of development and action perception 
theory to enhance developmental outcomes in high risk infants. The original version of 
SPEEDI consist of two phases where first phase is the intervention provided to the infants 
during the stay in NICU and phase two provided post discharge from NICU. For this study the 
infants will receive the interventions adapted from SPEEDI both as an outpatient based.  
                      The Phase I of the original version of SPEEDI consist of parent therapist collaborative 
sessions to understand infant cues, readiness for interaction, developmental support and 
stressors, ideas to promote interaction and development and watching the videos which is 
provided during the stay in NICU. However, this phase I intervention will be provided post 
discharge from the NICU at 40 weeks. The main objective of making parents watch these 
videos would be to help parents interact with their infant and perform the activities at home 
since most of the parents would be anxious and not know how to interact with their infant. The 
Phase II from the original version consisted of home visit to provide the intervention post 
discharge from NICU. It consists of therapist guiding the parents to perform play-based 
activities at home with their infants and these activities can be performed as a part of daily 
activities with their infants especially during feeding, bathing and changing diapers. There are 
5 main activities which the parents must perform with their infant at home. The activities are 
broken down into three stages that become progressively challenging over time. For this study 
purpose the phase II intervention will be provided at the hospital where the parent will need to 
bring their infant to the hospital and the 5 main activities will be broken down into two stages. 
During the monthly visit the principal researcher will assess and decide the infant’s ability to 
progress the activity from stage 1(easy) to Stage 2(hard). If the infant is found to be not ready 
to progress to the next stage, they will continue with the same activity. The primary caretaker 
will be given activity booklet which will contain pictures, simple text and log to record daily  

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            activities. To perform the play- based activities the primary caretaker will be asked to use toy 
within their natural home environment since the intervention does not require any specific or 
sophisticated toys. 
 
 
                         
Figure 4: Intervention Program 
 
 
 
 
 
 
Intervention  
40 weeks 
1 month 
2 months 
Activities  
• Watching videos 
to understand cue-
based interaction  
with the infant. 
• Introduce the 
activities that the 
parent can 
complete at home 
to promote 
midline and 
tracking of toys 
and faces  
• Watching 
people and toy  
• Tummy time  
• Holding head 
up  
• Kicking  
• Toy play  
• Watching 
people and 
toy  
• Tummy 
time  
• Holding 
head up  
• Kicking  
• Toy play  
 
Duration  
 20 mins/day 
20 mins/day  
20 mins/day  
Frequency  
5 days /week  
5 days /week  
5 days /week  

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Figure 5: Activity Description 
 
         The intervention will be provided as an outpatient based at JDWNRH by the principal 
researcher. It will require the parents to come to the hospital every month for the assessments and 
interventions. The parents will be called every week to ensure that they have no problem with the 
activities until the infant is 3 months of corrected age. The principal researcher will review and 
assess if the parents are performing the intervention correctly with the infant during the monthly 
visit. The parents in the intervention group will be advised not to share the activities and any 
information related to the intervention to other parents of preterm infants whom they might know. 
Activity  
Stage 1 
Stage 2  
Activity1 – Looking at 
people and toys (4 
minutes) 
• Looking at people with 
support in supine  
• In side lying and 
swaddled  
• Tracking of 
caregiver in supine.  
Activity 2- Tummy 
time (4 minutes)  
• Tummy time on the 
caregiver’s chest  
• Tummy time on 
the floor  
Activity 3- Holding 
head up (4 minutes) 
• Head control with help 
from caregiver. 
• Head control by 
swaddling the baby. 
• Head control with 
less support from 
caregiver, 
unswaddled. 
Activity 4- Kicking (4 
minutes) 
• Kicking with swaddle 
to support to support 
the arms. 
• Kicking with arms 
and legs free to 
move with slight 
support under the 
hips. 
Activity 5- Toy play (4 
minutes)  
• With use of external 
support to bring hands 
and legs in middle. 
 
• Toy play without 
external support 
and variety of 
position such as 
supine and side 
lying. 

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They will be given appointment for assessment at different day or time and the information 
regarding the enrollment will be kept confidential. 
Standard care group  
                          Standard care group will include education regarding early development which is 
present in the mother and child handbook and which is currently practiced. The standard care 
group will also be required to visit the clinic monthly and assessment will be performed monthly 
until the infant is 3 months of corrected age. During the monthly visit parents will be asked to 
report the amount of time spend with their infant performing the activity. 
             
 
1.4.9 Data Analysis  
               The researcher assistant who performed the randomization will register all neonatal 
data, discharge variables and the follow-up data, during the appointments. Motor 
performance of the infant will be assessed using TIMP at 40 weeks, 1 month,2 months and 3 
months of corrected age and neurodevelopment will be assessed using RNDA. Scores of 
TIMP items and items from RNDA will be transformed from categorical scale to a 
continuous scale. The Rasch Unidimensional Measurement Model (RUMM) will be used for 
this process. The number of sessions and amount of time spent performing the intervention 
will be recorded and analyzed. All the variables will have double data entry. 
 
              1.4.10 Statistical Analysis  
            Statistical analysis will be performed using Statistical Package for Social Sciences 
(IBM SPSS statistics for windows, version 28). Shapiro Wilk test will be used to test for 
normality of data. Descriptive statistics will be used to analyze patient’s demographic data. To 
investigate the effect of physical therapist intervention on motor performance two-way mixed 
ANOVA will be performed. To investigate the effect of physical therapy intervention on 
neurodevelopment two-way mixed ANOVA will be performed. The level of significance will 
be set at a p-value < 0.05. 
 
1.4.11 Data confidentiality 
            All research data and personal information will be under responsibility of the 
researchers in order to protect confidentiality before, during and after the trial. 
Confidentiality of data will be maintained by storing the filled proforma in a lockable cabinet 
and the electronic data file in a password protected computer accessible only to the 

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investigators. Dataset will be maintained securely for at least five years after completion of 
study.  
 
          
Funding 
Ministry of Health, Bhutan  
Health Volunteer Overseas 
Declaration of interest 
The author and co-authors involved in the study declare no conflict of interests. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ANNEXURE I 
Part I: Information Sheet  
 
Topic: The Effect of Modified Supporting Play, Exploration and Early Development 
Intervention on Motor Performance in Bhutanese Preterm Infants- Randomized Controlled 
Trial  
 
Principal Investigator: Karma Lhaki 
Address: Department of Physiotherapy, Jigme Dorji Wangchuck National Referral 
Hospital, Thimphu 
Contact number: +97517606492   Email:klhaki@jdwnrh.gov.bt 
 
Please take some time to read this information sheet. We are trying to compare the effect of 
customized physical therapy interventions provided by parents and standard care at 3 months 
of corrected age on motor performance in preterm infant’s post discharge from Neonate 
Intensive Care Unit (NICU). 
  
This study has been approved by the Institutional Review Board (IBR), KGUMSB, Bhutan, 
and will be conducted according to ethical guidelines and principles of the International 
Declaration of Helsinki, as well as Institutional Review Board (IBR), Bhutan.  
 
What is this study about?  
This research attempt to compare the effect of two types of interventions in preterm children 
post discharge from the NICU. One intervention is modified supporting play, exploration and 
early development intervention provided by parents. Another intervention is standard care 
which is normally practiced after your infant is discharged from the hospital. Your participation 
in the study is purely voluntary and you may refuse to participate or withdraw from the study, 
at any time, without any repercussions. 
 
Why have you been invited? 
Because your child was born pre-term and was admitted in NICU at JDWNRH.   
 
 What will be your responsibilities? 
As a parent/legal guardian who has consented to this study, you will be required to bring your 
child to pediatric physiotherapy unit, JDWNRH monthly till 3 months of corrected age and 
you will be required to perform the intervention which will be taught to by your therapist.   

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Will you benefit from this research?  
The intervention is designed to improve the developmental outcome of preterm infants who 
are at risk of developmental disabilities. The study findings may assist in planning appropriate 
policy and intervention for these vulnerable population of preterm infants.  
 
Are there any risks for you child in getting involved in this study?  
There are no invasive procedures involved during the assessment and while providing 
intervention. Both the assessment and intervention are delivered via play-based approach. 
Therefore, there is no risk involved. 
 
Will your child experience any discomfort for being part of this study?  
During the assessment we might ask you to remove the thick clothes, socks and mittens of your 
baby which might cause some discomfort but we will take extra care to avoid any discomforts 
to your baby. 
 
Who will have access to the results of this study? 
The information you provide is totally confidential and will not be disclosed to anyone. It will 
only be used for research purposes. Your name, address, and other personal information will 
be removed from the instrument, and only a code will be used to connect your name and your 
answers without identifying you. You may be contacted by the research team again only if it 
is necessary to complete the information on the study.  
 
Where can participants get results of the study should they wish to have them? 
You will get the details of the study results from the principal investigator and the Ministry of 
Health, Bhutan. 
             
Do you have any questions about the research?  
When you have read or listened to this information, the researcher will discuss it with you 
further and will answer any questions you may have. If you would like to know more about 
this study at any stage or have any queries about the study, please feel free to contact: 
 
 

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23
 
Karma Lhaki 
Department of Physiotherapy, Jigme Dorji Wangchuck National Referral Hospital, 
Thimphu, Bhutan  
Mobile: +97517606492 
Email: klhaki@jdwnrh.gov.bt 
 
If you have any complaints regarding this study, you may contact Chairperson of the 
Institutional Review Board (IRB), Khesar Gyalpo University of Medical Sciences of Bhutan, 
Thimphu, Bhutan at the following address: 
Institutional Review Board (IRB) 
Khesar Gyalpo University of Medical Sciences of Bhutan 
Thimphu, Bhutan 
Contact no: 02-338005 Ext# 2146 Email:  irbkgumsb@gmail.com  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Part II: Informed Consent form  
Section A: If the selected participant is a minor (less than 18 years of age) 
The parent or the legal guardian of the participants need to provide the informed consent. I 
have read the foregoing information, or it has been read to me. I have had the opportunity to 
ask questions about it and any questions that I have asked have been answered to my 
satisfaction. I consent voluntarily to allow my child to participate in this study. 
 
Name of Parent or legal guardian  
 
________________________________________________ 
 
Signature of Parent or legal guardian  
 
 
____________________________________________ 
 
Date ___________________________(Day/month/year) 
 
SECTION B: 
Statement by the researcher/person taking consent 
 
I have accurately read out the information sheet to the potential participant, and to the best 
of my ability made sure that the person understood it. I confirm that the participant was 
given an opportunity to ask questions about the study, and all the questions asked by the 
participant have been answered correctly and to the best of my ability. I confirm that the 
individual has not been coerced into giving consent, and the consent has been given freely 
and voluntarily. 
 
 
Name of researcher /person taking the consent 
 
_____________________________________ 
 
Signature of enumerator /person taking the consent 
 
 
__________________________________ 
 
 
Date ___________________________ (Day/month/year) 
 
 
 

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Section C: 
I have witnessed the accurate reading of the consent form to the potential participant, 
and the individual has had the opportunity to ask questions. I confirm that the individual 
has given consent freely. 
 
Name of witness  
 
 
________________________________________ 
 
Signature of witness  
 
 
 
_________________________________________ 
 
 
 
 
Date ________________________ (Day/month/year)