Skip to content

A study comparing effect of sensory stimulation on brain which will be assessed at 4 months age among preterm neonates admitted in neonatal ICU.

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 - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/058069
Enrollment
100
Registered
2023-09-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Multimodal intervention: The intervention will be multimodal intervention care (sensory stimulation) given to 34-week neonates by health care professionals during hospital stay followe

Sponsors

Dr Arti Maria
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants admitted in inborn NICU with gestational age Hemodynamically stable with/without non-invasive support . Availability of primary care giver

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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).Timepoint: 4 months corrected age

Secondary

MeasureTime frame
Proportion of Proportion of Proportion of Proportion of Timepoint: Discharge and at 4 months of corrected age.

Countries

India

Contacts

Public ContactSakshi Batra

Atal Bihari Vajpayee Institute of Medical Sciences & Dr. Ram Manohar Lohia Hospital

sakshi.batra2022@gmail.com8826748389

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026