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CTRI Number  CTRI/2024/09/074276 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 28/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral
Other (Specify) [neurobehavioral, Education]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Newborn Behavioral Observation (NBO) on Parent-baby bond and on the growth of early deliverd babies admitted at NICU unit. 
Scientific Title of Study   Effect Of Newborn Behavioral Observation (NBO) on Parent-Infant Interaction and On the Development of Haemodynamically Stable Pre-Term Infants admitted at NICU (Experimental Study). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
EC/56/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hemant Nandgaonkar 
Designation  Assistant Professor 
Affiliation  OT school and center seth gs medical college and kem hospital  
Address  occupational therapy department opd 412 ,seth.gs.medical college and kem hospital orthopedic center mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  9819660953  
Fax    
Email  hemantnandgaonkar@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Hemant Nandgaonkar 
Designation  Assistant Professor 
Affiliation  OT school and center seth gs medical college and kem hospital  
Address  occupational therapy department opd 412,seth.gs.medical college and kem hospital orthopedic center,parel,mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  9819660953  
Fax    
Email  hemantnandgaonkar@kem.edu  
 
Details of Contact Person
Public Query
 
Name  Hemant Nandgaonkar 
Designation  Assistant Professor 
Affiliation  OT school and center seth gs medical college and kem hospital  
Address  occupational therapy department opd 412 ,seth.gs.medical college and kem hospital orthopedic center mumbai.
occupational therapy department opd 412 ,seth.gs.medical college and kem hospital orthopedic center mumbai.
Mumbai
MAHARASHTRA
400012
India 
Phone  9819660953  
Fax    
Email  hemantnandgaonkar@kem.edu  
 
Source of Monetary or Material Support  
self sponsored 
 
Primary Sponsor  
Name  Hemant Nandgaonkar 
Address  20 pushpanjali goshala road mulund west,mumbai  
Type of Sponsor  Other [[self]] 
 
Details of Secondary Sponsor  
Name  Address 
Omkar Bhalekar   room no 4 ,Chandrakant Bhuvan,Hanuman galli ,kanjurmarg east,mumbai 42 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
drhemant nandgaonkar  Seth G.S. Medical College and KEM Hospital.  Occupational Therapy Department 412, Seth G.S. Medical College, Parel, Mumbai-12.
Mumbai
MAHARASHTRA 
9819660953

hemantnandgaonkar@kem.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC3) Seth GS Medical College KEM Hospital Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Newborn Behavioral Observations (NBO)   -The Newborn Behavioral Observations (NBO) is a relationship building, infant focused, individualized development based, family centered system. -It is a strength based interventional and observational tool consist of 18 neurobehavioral observations based on the 4 developmental agendas (Autonomic, Motor, State and Responsivity) which will be observe along with the parents in different behavioral states such as deep sleep , alert , crying, etc. -From those observations the clinician and parent will observe the strengths of baby and areas where they need support , and accordingly anticipatory guidance will be made which includes discussing sleep patterns and intervention for protection through environmenal modifications, discussion about musle tone and strength ,handling and support,discussion abput feeling cues,touch and contact, sleep position and safety,social interaction, discuss about visual capacities and hearing capacities and communication discussion about infants crying and Soothability techniques, self soothing,state regulation, stimulation threshold and strategies to provide support to parents and infants appropriate caregiving strategies will be provided by the parent as a intervention which results in neuroprotection. 
Comparator Agent  Standard of care(Non-NBO format)  It includes - Family centered approach and developmentally supportive care - Parent and caregiver education - Therapeutic Handling and neurodevelopmental positioning positioning - Provide appropriate positive sensory stimulation(Gentle massage, KMC.) - Environmental modifications - Feeding and Oro-motor interventions - Use of corrective splintage if needed - Home program. 
 
Inclusion Criteria  
Age From  7.00 Month(s)
Age To  8.50 Month(s)
Gender  Both 
Details  1.Preterm infants admitted at NICU whose gestational age will be from 28( less than 28 weeks mortality is around 80%)-34 weeks (as after 34 weeks they wont be admitted at NICU).
2.Infant’s NICU stay should be for at least 2 weeks.
3.The parents should understand Marathi, Hindi and English language.
4.Parents who are willing to participate in a study.
 
 
ExclusionCriteria 
Details  1.Infants born with congenital anomalies (Downs syndrome, spina bifida cleft palate, etc.)
2.Parents who doesn’t understand Marathi, Hindi and English language.
3.Parents who are unwilling to participate in the research study.
4.Mothers who are experiencing postpartum anxiety and depression regarding parenting.
5.Mother with known psychiatric disorder (schizophrenia, etc.).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To facilitate parent-infant interaction and to record the infant’s behavioral observations with observational tool Newborn Behavioral Observation (NBO) at NICU unit.
 
NICU stay and Discharge  
 
Secondary Outcome  
Outcome  TimePoints 
2.To Enable parents to identify the needs of the infants and provide them by appropriate anticipatory caregiving strategies for infant’s self-regulation.
3.To Measure the outcomes of parent-infant relationship  
NICU stay and Discharge  
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   05/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

•        From total 68 sample size 34 infants will be selected for experimental group (who receive NBO) and 34 infants under controlled group (who received standard of care without NBO).

•       Experimental group: The principal investigator (PI) will involve in experimental study as he is certified in conducting newborn behavioral observations (NBO). Through family centered approach of NBO rapport building will be initiated and parents will ask about their experience of their baby and explained about the importance of these newborn behaviors. 18 items infant focused newborn observations (NBO) will be administered in a flexible way on different states of infants (habituation items when infant is in deep sleep, motor responses, responsiveness to parent’s voices and face when infant will be in alert state) under experimental group.

•       The caregiver(mother) will be observing those behaviors along with therapist. The observations of the infants are recorded on the NBO sheet and on anticipatory guidance checklist (which provide the intervention to baby by parents) will be made to guide the parents.

•       Anticipatory guidance to the parents as an important form of intervention

                                 Newborn behavioral observations (NBO)

Anticipatory guidance provided by the therapist to parents

Newborn behavioral observations(NBO)

Anticipatory guidance provided by the therapist to parents

1. habituation to light

Sleep patterns will be  discuss with parent for interaction and intervention with the baby

10.visual response

Vision guidance will be  by providing stimulation, awareness to parents about the visual capacities.

2. habituation to sound

Sleep protection by environmental modifications,  Swaddling,   Consolabality .

11. orientation to voice

Hearing of baby by helping parents aware about the infants tolerance to the auditory stimulation. Stress signals.

3. muscle tone of legs and arm

Muscle tone by facilitatory such as light touch heavy joint compression, etc. and inhibitory techniques by swaddling and regular handling of baby, support.

12. orientation to sound

Hearing  helping them aware about the infants tolerance to the auditory stimulation.

4. rooting

Feeding cues of infants and discuss about appropriate technique and stimulation.

13. visual tracking

Communication cues by discussing signs of stress cues and approach cues. 

5.sucking

Feeding cues of infants and discuss about appropriate technique and stimulation.

14. crying

Crying and Soothability by different comforting and consolidation techniques.

6.hand grasp

Touch and contact by holding, handling and swaddling.

15. Soothability

Self soothing by helping parent to understand infants self soothing techniques hand to mouth or any other methods.

7. shoulder and neck tone

Muscle tone by facilitatory and inhibitory techniques, handling, support.

16.state regulation

State regulation by discussing overall organization of the infants behavior.    

provide concept of goodness of fit by helping parents to adopt to unique states of infants.

8. crawling response

Sleep and safety infant be put down to sleep on her back-back to sleep -to avoid risk sudden infant death syndrome (SIDS)

17.response to stress

 

9.response to face and voice

Social interaction by helping parents to understand kinds of interactions and stimulation best for the infants.

18. activity level

Stimulation threshold by discussing kinds of stimulation that may overwhelm the child and how parents can modify through support and environmental support. Also discuss about strategies help to settle the infant like holding, swaddling.

 

      



























                                                                                                                                                                                                                                                                                                                                                                                      































The details of other interventions and implications for caregiving mentioned above in NBO.    

 The administered items of NBO whether habituation or motor are scored on a three-point scale, with one point being assigned to weak (weak neck tonus, for instance) or altered responses (very intense stress signal instance), two points to transition behaviors, and three to well-established behaviors (easy habituation to light and sound, for instance) in first visit of NBO in NICU.

•           In further visits if infants will be in different state per say crying the other NBO behaviors like consolability, state regulation and will be scored on the same case record form and followed up of the intervention which was given in first visit. So, likewise everyday when therapist will be visiting NICU he will be taking follow up of the interventions which was taught before to the parents.

•       Through above the Infant’s strengths and areas where he/she needs support will be enlisted and therapist will provide appropriate anticipatory caregiving strategies (positioning, tone management, improve sleep quality, swaddling, improve Oro-motor functions, facilitate the capacity for self -regulation) as an intervention that helps to promotes the development of a positive Clinician–Family Partnership.

•       Controlled group : The co-investigator will provide the intervention to infants under controlled group will be provided with standard of care treatment without performing newborn behavioral observation (NBO).

•        As these infants will be from NICU unit so during performing any items if infants level of arousal falls below normal, skin becomes pale and show irregular breathing then will either take pause or discontinued further items Use of traffic like Metaphor,  where green light denotes stable state of infant so to continue with further items, yellow light denotes stress on infant so need to take pause before administering further items and after pause once infant becomes stable then further items carried out with adequate pause in between and red light  signifies that discontinue with further items as infant is showing severe stress signs like tremulousness and startles with irregular breathing not recovering even after adequate rest interval and send the infant back to ward and informed immediately to the on duty neonatologist ).

•       Parents also taught about these stress signs while providing NBO and providing appropriate specific interaction like startles, tremulousness or change in skin Colour, breathing patterns during interacting and providing anticipatory strategies.

•       Though the methodology will have multiple scales and assessment but they will be used at different time frames.

•       The following are the details of followed up which will be measured 1 moth of corrected age of the baby at different settings.

•       The outcome of parent-infant relationship will be measured by using, post-partum bonding questioner at Occupational therapy OPD (079) this questionnaire is a self reported and fill up by the caregiver (mother) in a language best understood by them.as translations are done in Hindi , Marathi and English language ,and neurodevelopmental outcome of this relationship on baby will be measured by BSID-4 when infants from both groups will visit at KMC OPD of KEM Hospital.

•        Here the BSID will help in assessing the impact of this parent-infant relationship on development on infant and screen out the risk of developing neuro-developmental delays, in these preterm infants so future early intervention will be plan.

     

                  Assessments

 Settings where   assessments will be taken

NBO as a intervention along with multiple followed ups

NICU unit of KEM hospital

Postpartum bonding questionnaire (PBQ)

At occupational therapy department 079 of KEM hospital after 1 month of their corrected age

Neurodevelopmental outcomes will be measured by using BSID-4

At the KMC OPD of KEM hospital after 1 month o their corrected age

 

•       The total score of parent-infant interaction through PBQ and neuro-developmental outcomes by on both groups will be calculated and then comparison will be made between experimental and control groups to know the effectiveness of NBO.

 
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