| CTRI Number |
CTRI/2023/09/058069 [Registered on: 27/09/2023] Trial Registered Prospectively |
| Last Modified On: |
25/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [multimodal sensory stimulation] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study comparing effect of sensory stimulation on brain which will be assessed at 4 months age among preterm neonates admitted in neonatal ICU. |
|
Scientific Title of Study
|
Effect of multimodal intervention on cognitive outcome assessed at 4 months corrected age among 34 weeks neonates admitted in neonatal intensive care unit : An open label randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Batra |
| Designation |
Senior resident |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences & Dr. Ram Manohar Lohia Hospital |
| Address |
Atal Bihari Vajpayee Institute of Medical Sciences and
Dr. Ram Manohar Lohia Hospital Baba Kharak Singh Marg Near Gurudwara Bangla Sahib Connaught Place New Delhi.
Central
DELHI
110001
India |
| Phone |
8826748389 |
| Fax |
|
| Email |
sakshi.batra2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi Batra |
| Designation |
Senior resident |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences & Dr. Ram Manohar Lohia Hospital |
| Address |
Atal Bihari Vajpayee Institute of Medical Sciences and
Dr. Ram Manohar Lohia Hospital Baba Kharak Singh Marg Near Gurudwara Bangla Sahib Connaught Place New Delhi.
Central
DELHI
110001
India |
| Phone |
8826748389 |
| Fax |
|
| Email |
sakshi.batra2022@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Batra |
| Designation |
Senior resident |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences & Dr. Ram Manohar Lohia Hospital |
| Address |
Atal Bihari Vajpayee Institute of Medical Sciences and
Dr. Ram Manohar Lohia Hospital Baba Kharak Singh Marg Near Gurudwara Bangla Sahib Connaught Place New Delhi.
Central
DELHI
110001
India |
| Phone |
8826748389 |
| Fax |
|
| Email |
sakshi.batra2022@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute of Medical Sciences and
Dr. Ram Manohar Lohia Hospital
Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Dr Arti Maria |
| Address |
Atal Bihari Vajpayee Institute of Medical Sciences and
Dr. Ram Manohar Lohia Hospital
Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arti Maria |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001
Central
DELHI |
9818618586
artimaria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,ABVIMS,Dr. RML Hospital , New Delhi. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional care |
The control group will receive the routine Conventional care according to the NICU protocols, including Kangaroo Mother Care (KMC), nesting, minimal handling, non-pharmacological pain management and family participatory care and included parental training (based on the FCC program. |
| Intervention |
Multimodal intervention |
The intervention will be multimodal intervention care (sensory stimulation) given to 34-week neonates by health care professionals during hospital stay followed by parents or primary care giver (after proper training) after discharge in a proper structured way, designed according to gestation by the experts. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
Preterm infants admitted in inborn NICU with gestational age <34weeks confirmed by first-trimester ultrasound/ Expanded, New Ballard Score or admitted to the referral outborn neonatal unit at a postnatal age of not more than 3 days.
Hemodynamically stable with/without non-invasive support .
Availability of primary care giver
|
|
| ExclusionCriteria |
| Details |
Refusal to consent.
Any gross major malformation (e.g. neural tube defect associated with gross neurological deficit, anencephaly, and trisomies).
Any neonate who had been admitted on accord of being abandoned.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of < 34 weeks neonates, with abnormal cognitive outcome, per output variables which are measures of basic attention and intersensory processing skills, at 4 months of corrected age in the two groups as assessed by eye tracker based on Multimodal Attention Assessment Protocol (MAAP). |
4 months corrected age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of < 34 weeks neonates with abnormal neurological examination HNNE at discharge.
Proportion of <34 weeks neonates with favorable response to infant mother bonding as assessed by Mother Infant Attachment Scale at discharge.
Proportion of < 34 weeks neonates with favorable scores as assessed by Neurobehavioral Observation Scale at discharge.
Proportion of <34 weeks neonates with abnormal neurological examination HINE at 4 months
|
Discharge and at 4 months of corrected age. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
10/10/2023 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is a open label randomised control trial to see effect of multimodal intervention on cognitive outcome assessed at 4 months corrected age among< 34 weeks neonates admitted in neonatal intensive care unit .Control arm will receive conventional care as per unit protiocol and intervention group will receiive multimodal sensory stimulation by trained doctors and nurses which will be appropriate for gestationakl age. Then primary outcome will be asseessed by eye tacker at 4 monthjs of corrected age . |