Immediate KMC neurodevelopmental follow-up study.

Not Applicable

• Registration Number: CTRI/2019/11/021899
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All babies born alive in the participating hospitals, with birth weight between 1.0 to less then 1.8 kg, enrolled in parent study & survive the first 28 days of life are eligible for participation in this trial with their mothers. The mother-baby pair is still eligible if the mode of delivery is caesarean section, if the babies are twins or if the mother experiences some complications during labour and delivery that are expected to resolve

within 3 days.

Exclusion Criteria

1.Exclusion criteria (parent study)

(i) the mother is younger than 15 years of age

(ii) the mother (or her guardian in case mother is a minor aged 15-17

years) is unable or unwilling to provide consent;

(iii) the mother is unlikely to be able to provide KMC for the first 3

days after birth, e.g. she has eclampsia, shock or has undergone

major surgery;

(iv) the baby is unable to breathe spontaneously within 1 hour of

birth;

(v) multiple pregnancy: triplets or more;

(vi) the baby has a congenital malformation that interferes with the

intervention, or the intervention interferes with the required care for

the congenital malformation;

(vii) the place of residence is not a part of the defined study area (the

study area will be defined to make 28-day follow up home visit

feasible)

(viii) If for any reason the mother baby pair cannot be enrolled within 2 hours of birth of the baby.

2. Exclusion criteria (current study)

(i) The mother or guardian is unwilling to provide the consent.

(ii)The mother infant duo are unwilling to come for follow-up visits.

(iii)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
I. Developmental delay <br/ ><br>II. Cerebral palsy <br/ ><br>III. Hearing impairment <br/ ><br>IV. Vision impairment <br/ ><br>V. EpilepsyTimepoint: I. Between 24 to 30 month chronological age. <br/ ><br>II. 6,12 and 24 month <br/ ><br>III. before 3 Month <br/ ><br>IV. 12 month <br/ ><br>V. 3,6,9,12,15,18,21,24 month

Secondary Outcome Measures

Name	Time	Method
Feeding practicesTimepoint: 3,6,9,12,15,18,21,24 month;GrowthTimepoint: at 6,12 and 24 months of age;Home environmentTimepoint: 18 months;Maternal depressionTimepoint: 6 and 12 months of age;MortalityTimepoint: between 3 months of age and 2 years of age