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
- Conditions
- Communication and cognitive development
- Registration Number
- SLCTR/2022/001
- Lead Sponsor
- Yvonne Weerasinghe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- Not specified
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.
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
- Primary Outcome Measures
Name Time Method The mean composite language and cognitive scores in the intervention and the standard care groups measured using Bayley III cognitive scores and language skills scores. [Six months after commencement of the intervention]<br> [ ]<br> []<br> [ ]<br> [ ]<br> []<br> []<br> []<br> []<br> [ ]<br> []<br> [ ]<br> [ ]<br> []<br>
- Secondary Outcome Measures
Name Time Method Psychological health of the primary care giver as determined by the Depression, Anxiety and Stress Scale- 21 (DASS-21), validated for the Sri Lankan population. (According to the standardized interpretation of this scale recommended cut-off scores for conventional severity labels (normal, mild, moderate, severe, extremely severe) for each subscales of depression, anxiety and stress will be used for analysis) [At baseline and six months after commencement of the intervention ]<br>