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Infections and growth in low birth weight infants: Role of community initiated kangaroo mother care on breast milk and underlying biological pathways

Effect of community initiated kangaroo mother care in low birth weight infants on linear growth, infection reduction, breast milk properties and related biological outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/04/008430
Enrollment
4600
Registered
2017-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: KMC: Promotion of and support to provide early skin to skin care as soon as possible after birth initiated at the community. Support for breastfeeding to promote optimal breastfeeding p

Sponsors

Centre for Health Research and Development Society for Applied Studies
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Singleton Low birth weight babies (>=1500 to <=2250 g) included in the trial titled â??Effect of Community Initiated Kangaroo mother care on babies with Low Birth Weightâ?? who are either born at home or hospital but KMC not initiated in the hospital.

Exclusion criteria

Exclusion criteria: 1.Infant unable to feed 2.Infant has breathing problem or is less active 3.Twins or triplets 4.Gross congenital malformations 5.Mother does not intend to stay in the study area for the next 6 months

Design outcomes

Primary

MeasureTime frame
1. LAZ score (4600 sample size) 2. Postpartum depressive symptoms (1950 sample size)Timepoint: End of neonatal period

Secondary

MeasureTime frame
Breast milk antimicrobial proteins(in a sub sample)Timepoint: 3rd week of life;Breastfeeding performance: successful breastfeeding, lactation failure and use of breast milk substitutes (in a sub sample)Timepoint: at the end of neonatal period;Gut inflammatory markers: Fecal Calprotectin, Myeloperoxidase, alpha1antitrypsin(in a sub sample)Timepoint: at the end of neonatal period;Infant breast milk intake during the neonatal period (sub sample of 550 infants)Timepoint: neonatal period;LAZ and WHZ scoreTimepoint: 3 and 6 months;Maternal stress and cortisol levels(sub sample of 550)Timepoint: at the end of neonatal period;Relative abundance of and diversity of infant gut microbiome (in a sub sample)Timepoint: at the end of neonatal period

Countries

India

Contacts

Public ContactDr Sarmila Mazumder

Centre for Health Research and Development, Society for Applied Studies

bireshwar.sinha@sas.org.in011-46043751-55

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026