A randomized controlled trial for a family- centered, early intervention package for infants who are born with high risk for Neuro- Developmental Disabilities at two government maternity hospitals in Colombo district, to promote language development during early infancy

Not Applicable

Completed

• Conditions: Communication and cognitive development

• Registration Number: SLCTR/2022/001
• Lead Sponsor: Yvonne Weerasinghe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

1.Male and female infants aged between birth to 8 weeks at the point of discharge from hospital
2.Infants at high risk for neuro developmental disabilities such as hypoxic ischemic encephalopathy, prematurity, neonatal seizures, jaundice requiring double photo therapy or exchange transfusion, neonatal meningitis and sepsis, neonates requiring ventilation, hypotension requiring inotropes, intra cranial hemorrhages following neonatal complications and requiring NICU care more than one week
3.Families who are willing to commit for a follow up period of six months.
4.Infants who will be residing in the Colombo District during the follow up period.

Exclusion Criteria

1. Infants who have major dysmorphism according to the clinical evidence will be excluded from the study referring the diagnosis cards.
2. Infants who are referred to tertiary maternity hospitals for advanced peri-natal care and will be returning to their respective districts.
3. Mothers who may have less family support and/ or intellectual abilities to carry out the interventions: single mothers, mothers with intellectual disability.
4. Infants whose mothers have physical/ mental illnesses which requires intensive medical attention during immediate peri-natal period eg: liver failure, heart failure, postpartum depression also will be excluded from the study.

The 3rd and 4th exclusion criteria will be determined by probing the social and medical history/ records of the mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified