Implementation at Scale and Evaluation of KMC

NCT06130488 | Completed DMC

• 1 other identifier: 2021-6444-19970
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this quasi-experimental study design is to look at feasibility and document the process and challenges of implementing KMC at scale in district Sanghar (Sindh) and Lasbella (Balochistan) . The main question it aims to answer are:

• Does the KMC is feasible to be implemented in rural areas?
• What is the process and challenges in implementing KMC in rural areas?
• Pregnancy surveillance is going in the secondary level care hospitals and in its catchment population. Recruitment of babies is carried who are low birth weight (less than 2000grams).
• Mothers taught to administer KMC by physician and nursing /LHV staff in the facility within first 6 hours after delivery and continue till the mother and baby are discharged by trained facility KMC management team.
• After training and administration of KMC at facility for 72 hours, the mother and baby pair discharged and followed up at home by the team including project-based data collector and respective LHWs.
• KMC Champions are in development for community mobilization and conducting sessions at village level.
• We will compare pre and post intervention change in practices at facility level and at individual level of household and assess the KMC coverage.

Conditions

Newborn Morbidity

Keywords

Low birth weight; Kangaroo Mother Care; Newborn care

Outcome Measures

Primary Outcomes (1)

• Number of infants having birth weight of 2000 grams received Kangaroo Mother Care (KMC)

  Low Birth weight (\<2000grams) infants enrolled and received at the implementation sites (secondary level care hospitals and their catchment population) in two districts

  Through study completion, average 2 years

Secondary Outcomes (3)

• Increase in exposure to KMC priming interactions in the antenatal period

  Through study completion, average 2 years

• Proportion of the health facilities providing KMC services

  Through study completion, average 2 years

• Number of infants received early Initiation and Exclusive breast feeding

  Through study completion, average 2 years

Study Arms (1)

KMC implementation

EXPERIMENTAL

KMC phases implemented as per the protocol

Behavioral: KMC

Interventions

KMC BEHAVIORAL

KMC implementation as per protocol

KMC implementation

Eligibility Criteria

• Age: 30 Minutes - 42 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Baby weighing between ≥1200 to \<2000grams

You may not qualify if:

• Well small baby; less than 1200 grams
• Baby more than 2000g
• Danger signs such as
• Severe infections
• Apnea
• Congenital malformation

Sponsors & Collaborators

• Aga Khan University: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 47800, Pakistan

Location

Study Officials

• Zulfiqar Bhutta, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguish Professor

Model Details: Quasi experimental study model with pre and post intervention evaluation,

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: November 14, 2023
• Study Start: January 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)