A study comparing effect of sensory stimulation on brain which will be assessed at 4 months age among preterm neonates admitted in neonatal ICU.
Phase 4
Not yet recruiting
- Conditions
- Pregnancy, childbirth and the puerperium,
- Registration Number
- CTRI/2023/09/058069
- Lead Sponsor
- Dr Arti Maria
- 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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
🇮🇳Central, DELHI, India
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital🇮🇳Central, DELHI, IndiaDr Arti MariaPrincipal investigator9818618586artimaria@gmail.com