| 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
|
|
|
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
|
|
|
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. |