NCT03098069

Brief Summary

This implementation research aims to accelerate effective and high coverage of Kangaroo Mother Care in district Sonipat in the state of Haryana, India. The project is being led by government of Haryana. KMC units will be set up in selected government and private delivery facilities. KMC will be initiated for all babies with birth weight less than 2000 gm in the facilities (either in born or referred from elsewhere) and continued at home post discharge. These babies may be either born in the facility or referred to the facility. A linkage with community health workers will be established to support mothers to continue KMC at home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
911

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 19, 2019

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

March 16, 2017

Last Update Submit

September 18, 2019

Conditions

Keywords

Kangaroo Mother CareLow Birth WeightImplementation research

Outcome Measures

Primary Outcomes (2)

  • Effective coverage of KMC at discharge from hospital

    Proportion of babies who weighed less than 2000g at birth and got KMC for atleast 8 hours and were exclusively breastfed in the last 24 hours, assessed at discharge.

    At the time of discharge from hospital, will vary with each baby

  • Effective coverage of KMC at home, 7 days after hospital discharge

    Proportion of babies who weighed less than 2000g at birth and got KMC for atleast 8 hours and were exclusively breastfed in the last 24 hours, assessed at 7 days after hospital discharge.

    7 days after discharge from hospital

Secondary Outcomes (5)

  • Population-level duration of KMC

    First 28 days of life

  • Any KMC received

    First 28 days of life

  • Infants exclusively breastfed

    First 28 days of life

  • Neonatal mortality

    1 year

  • Cost of KMC scale up

    1 year

Study Arms (1)

KMC Scale up in a district

This is an implementation research project on scaling up KMC in selected government and private health facilities in an entire district, aiming to cover newborns weighing less than 2000gms at birth.

Eligibility Criteria

Age1 Minute - 28 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study participants will include babies of birth weight less than 2000g born in the study area. Newborns who are severely sick according to pre-defined criteria will have the initiation of KMC delayed until they have stabilized.

You may qualify if:

  • Babies with birth weight less than 2000g born in the study area.

You may not qualify if:

  • Newborns who are severely sick will have the initiation of KMC delayed until stabilization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRD, Society for Applied Studies

Sonīpat, Haryana, 131001, India

Location

Related Publications (2)

  • Mony PK, Tadele H, Gobezayehu AG, Chan GJ, Kumar A, Mazumder S, Beyene SA, Jayanna K, Kassa DH, Mohammed HA, Estifanos AS, Kumar P, Jadaun AS, Hailu Abay T, Washington M, W/Gebriel F, Alamineh L, Fikre A, Kumar A, Trikha S, Ashebir Gebregizabher F, Kar A, Bilal SM, Belew ML, Debere MK, Krishna R, Dalpath SK, Amare SY, Mohan HL, Brune T, Sibley LM, Tariku A, Sahu A, Kumar T, Hadush MY, Gowda PD, Aziz K, Duguma D, Singh PK, Darmstadt GL, Agarwal R, Gebremariam DS, Martines J, Portela A, Jaiswal HV, Bahl R, Rao Pn S, Tadesse BT, Cranmer JN, Hailemariam D, Kumar V, Bhandari N, Medhanyie AA; KMC Scale-Up Study Group. Scaling up Kangaroo Mother Care in Ethiopia and India: a multi-site implementation research study. BMJ Glob Health. 2021 Sep;6(9):e005905. doi: 10.1136/bmjgh-2021-005905.

  • Medhanyie AA, Alemu H, Asefa A, Beyene SA, Gebregizabher FA, Aziz K, Bhandari N, Beyene H, Brune T, Chan G, Cranmer JN, Darmstadt G, Duguma D, Fikre A, Andualem BG, Gobezayehu AG, Mariam DH, Abay TH, Mohan HL, Jadaun A, Jayanna K, Kajal FNU, Kar A, Krishna R, Kumar A, Kumar V, Madhur TK, Belew ML, M R, Martines J, Mazumder S, Amin H, Mony PK, Muleta M, Pileggi-Castro C, Pn Rao S, Estifanos AS, Sibley LM, Singhal N, Tadele H, Tariku A, Lemango ET, Tadesse BT, Upadhyay R, Worku B, Hadush MY, Bahl R; KMC Scale-Up Study Group. Kangaroo Mother Care implementation research to develop models for accelerating scale-up in India and Ethiopia: study protocol for an adequacy evaluation. BMJ Open. 2019 Nov 21;9(11):e025879. doi: 10.1136/bmjopen-2018-025879.

Study Officials

  • Sarmila Mazumder, MBBS, PhD

    CHRD, Society for Applied Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 31, 2017

Study Start

August 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

September 19, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

Locations