Implementation Research of Kangaroo Mother Care in Rural Pakistan.

NCT03545204 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2020-04-09

No results posted yet for this study

Summary

Pakistan has a high neonatal mortality rate (55/1000 live birth)(1) and each year more than 200,000 newborns die. In rural Pakistan, more than 50% deliveries occur at home and majority by unskilled birth attendants(2). The country has a high proportion of preterm births and according to unpublished data it ranges between 15-20% of all live births. Prematurity is one of the 3 main causes of neonatal deaths (14.1%)(3). While many interventions exist to save the preterm newborns, KMC is considered as a simple, close to nature and cost-effective intervention. There are evidence to suggest that KMC, compared to incubator care, lowers the neonatal mortality by 51% for stable babies weighing \<2,000 g if started in the first week. In this study; early, prolonged and continuous direct skin-to-skin contact is provided to preterm newborn by the mother or another family member to provide warmth and to encourage frequent and exclusive breastfeeding.

The investigators intend to evaluate the impact of a KMC Package on the uptake of KMC in the community and its effect on neonatal mortality , exclusive breastfeeding rates , weight gain, neurodevelopment outcomes. This will be a cluster randomized controlled trial to be implemented in the rural union councils of District Dadu. The unit of randomization will be union councils.

Conditions

  • Low-Birth-Weight Infant

Interventions

OTHER

Kangaroo Mother Care Package

The KMC package will include creation of KMC Champions from within the community, social mobilization to create awareness and its acceptance with families using powerful IEC tools such as docudrama, flip charts, pictorials in local languages; engagement of community and community leaders, capacity building of health care providers on Kangaroo mother care, essential newborn care ENC, policy dialogues with stake holders in the public and private sectors and delivery of a "KMC kit " to the pregnant female by the Implementation team

OTHER

Routine Standard Care

Routine Standard Care ( essential Newborn care )ENC

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER
  • Aga Khan University

    lead OTHER

Principal Investigators

  • Zulfiqar A Bhutta, FCPS, PhD · Aga Khan University and Hospital

  • Dr Sajid B Soofi, MBBS, FCPS · Aga Khan University

  • Dr Shabina Ariff, MBBS, FCPS · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Minutes
Max Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-09-30
Completion
2021-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03545204 on ClinicalTrials.gov