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Clinical Trials/SLCTR/2022/001
SLCTR/2022/001
Completed
N/A

Family- centered, early intervention package for infants at high risk for Neuro- Developmental Disabilities to promote language development during early infancy; a randomized controlled trial

Yvonne Weerasinghe0 sitesTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Communication and cognitive development
Sponsor
Yvonne Weerasinghe
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Yvonne Weerasinghe

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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