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Impact of early prolonged Kangaroo Mother Care on normal birth weight infants.

Can Kangaroo Mother Care (KMC) during the first 72 hours lead to improved breastfeeding and growth among normal birth weight newborns? - A randomized controlled trial. - NIL

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/062057
Enrollment
516
Registered
2024-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: P809- Hypothermia of newborn, unspecified

Interventions

Intervention1: Intervention Arm: KMC (Skin to Skin) intervention to normal birth weight babies for 48 to 72 hours: - Mothers in the intervention group will receive education and counseling happened im

Sponsors

Indian Council of Medical Research
Lead Sponsor
Community Empowerment Lab
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy singleton newborns with birth weight greater than equal to 2500 grams, born vaginally and screened and enrolled within 4 hours of birth. 2.Residing within the catchment area near the study facility 3. Having singleton vaginal births in the study facility without any complications 4. Willing to stay in the study facility for 48 hours post-delivery and continue recommended practices at home post-discharge 5. Provide written informed consent for study participation within 4 (four) hours of birth.

Exclusion criteria

Exclusion criteria: Newborns: 1) Any condition that will require immediate admission to the neonatal intensive care unit (NICU/ SNCU) such as respiratory distress, birth asphyxia etc 2) Newborn should not be enrolled in any other research study that would interfere with the intervention and outcomes. 3) Having major congenital malformations which are apparent at birth that can interfere with the intervention like anencephaly, hydrocephalus, omphalocele, cleft lip, cleft palate, meningomyelocele, imperforate anus. Mothers: 1) Maternal death 2) Multiple births 3) Caesarean section delivery 4)Women with HIV opting for top feeding 5) Any complications e.g. post partum haemorrhage (PPH), eclampsia, etc. identified within an hour of birth, requiring special or intensive care beyond routine postnatal care 6) Any other problems, such as generalized skin rashes/ infection, that may hinder their ability to provide prolonged KMC

Design outcomes

Primary

MeasureTime frame
1) Percentage weight change over the first 48 hours after birth. 2) The weight gain velocity during the newborn period 3) Quality of breastfeeding as measured through the Bristol Breastfeeding Assessment Tool (BBAT) score on Day 8 Timepoint: 1) 48 hours of birth 2) After the newborn reaches 28 days of age 3) After the newborn reaches 28 days of age

Secondary

MeasureTime frame
Exclusive Breastfeeding at day 28 of birthTimepoint: After the newborn reaches 28 days of age;Score on the Breastfeeding Experience Scale as reported by motherTimepoint: At 8 days of birth;Possible Serious Bacterial Infection (PSBI) among infantsTimepoint: 4, 8, 15 & 29 days of birth.;Maternal depression measured at 15days after birthTimepoint: At the age of 15 days;Mother-to-infant bonding scale measured on day 29Timepoint: After the newborn reaches 28 days of age;Breastfeeding self-efficacy scale (short form) measured on day 29Timepoint: After the newborn reaches 28 days of age

Countries

India

Contacts

Public ContactVinay Pratap Singh

Community Empowerment Lab

aarti.kumar@celworld.org919936060008

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 17, 2026