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Implementation Research of Kangaroo Mother Care in Rural Pakistan. (KMC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03545204
Recruitment Status : Unknown
Verified April 2020 by Dr Shabina Ariff, Aga Khan University.
Recruitment status was:  Recruiting
First Posted : June 4, 2018
Last Update Posted : April 9, 2020
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Dr Shabina Ariff, Aga Khan University

Brief 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 The country has a high proportion of preterm births and according to unpublished data it ranges between 15-20% of all live births.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.


Condition or disease Intervention/treatment Phase
Low-Birth-Weight Infant Other: Kangaroo Mother Care Package Other: Routine Standard Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A Community based Cluster Randomized Control Trial Group 1: Community Kangaroo Mother Care cKMC will be provided to low birth weight babies of randomly selected union councils.

Group 2: Essential newborn care will be provided as per standard country protocol Group 2: Only facility KMC and routine standard care is provided to low birth weight babies of randomly selected union councils.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants,and outcome assessor will be masked about the intervention provided in the other arm.
Primary Purpose: Prevention
Official Title: Implementation Research for Introducing Sustainable Uptake of cKMC Intervention Package in Rural Pakistan. A Community-based Cluster Randomized Controlled Trial.
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention Clusters
Community based Kangaroo Mother Care,KMC package in low birth weight infants of randomly selected union councils.
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 Name: community KMC package

Control clusters
Essential newborn and routine standard care in low birth weight infants of randomly selected union councils.
Other: Routine Standard Care
Routine Standard Care ( essential Newborn care )ENC




Primary Outcome Measures :
  1. Neonatal mortality [ Time Frame: 2 years ]
    Primary outcome is to reduce 30% neonatal mortality in low birth weight babies (≥1200g - ≤2500g)


Secondary Outcome Measures :
  1. Exclusive breast feeding [ Time Frame: 6 months of age ]
    Increase in the rate of exclusive breast feeding up to 50%.

  2. Growth monitoring through Anthropometric measures [ Time Frame: 1, 3 and 6 months ]
    Anthropometric measurements including weight in grams, length in centimeter and head circumference in centimeter will be recorded through Seca weighing scale 376, Infantometer and measuring tape for head circumference measurement of low birth weight babies at different time points from birth till 6 months of age. All measurements will be recorded on WHO growth charts.

  3. Possible severe bacterial infection [ Time Frame: 1st and 2nd months of age ]
    Reduction in the possible severe bacterial infection in low birth weight babies.

  4. Neurodevelopment assessment [ Time Frame: 6, 9, 12 and 24 months ]
    Neurodevelopment assessment through "Bayley Scales of Infant and Toddler Development- Third edition" will be used in a subset of recruited Low birth weight babies at different time points till 2 years of age.

  5. Cost-effectiveness of KMC implementation model [ Time Frame: 2 years ]
    Cost-effective assessment of KMC implementation model will be done by using Markov model.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mother or family consents to participate in the trial.
  • All stable preterm small baby weighing (≥1200-<2500 grams) are eligible for participating in the study. Mother's agreement to stay in health facility for 72 hours to implement KMC.

Exclusion Criteria:

  • Well small baby; less than 1200 grams and baby more than 2500 grams will be excluded.
  • Babies presenting with danger signs and congenital malformation will be excluded and referred to advance care facility.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545204


Contacts
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Contact: Dr Shabina Ariff, MBBS, FCPS +92 21 34864357 ext 4357 shabina.ariff@aku.edu
Contact: Asghar Ali, MRA,MBA 92 213 493 0051 ext 2279 asghar.ali@aku.edu

Locations
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Pakistan
THQ Johi Recruiting
Dadu, Sindh, Pakistan
THQ Khairpur Nathan Shah Recruiting
Dadu, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
Bill and Melinda Gates Foundation
Investigators
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Study Chair: Zulfiqar A Bhutta, FCPS, PhD Aga Khan University and Hospital
Study Director: Dr Sajid B Soofi, MBBS, FCPS Aga Khan University
Principal Investigator: Dr Shabina Ariff, MBBS, FCPS Aga Khan University
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Shabina Ariff, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03545204    
Other Study ID Numbers: KMC Implementation Trial
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Shabina Ariff, Aga Khan University:
Community Kangaroo mother care
Low birth weight
Additional relevant MeSH terms:
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Birth Weight
Body Weight