Implementation Research of Kangaroo Mother Care in Rural Pakistan. (KMC)
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|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
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 The country has a high proportion of preterm births and according to unpublished data it ranges between 15-20% of all live births.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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|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.|
|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|
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
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
- Neonatal mortality [ Time Frame: 2 years ]Primary outcome is to reduce 30% neonatal mortality in low birth weight babies (≥1200g - ≤2500g)
- Exclusive breast feeding [ Time Frame: 6 months of age ]Increase in the rate of exclusive breast feeding up to 50%.
- 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.
- Possible severe bacterial infection [ Time Frame: 1st and 2nd months of age ]Reduction in the possible severe bacterial infection in low birth weight babies.
- 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.
- Cost-effectiveness of KMC implementation model [ Time Frame: 2 years ]Cost-effective assessment of KMC implementation model will be done by using Markov model.
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
|Contact: Dr Shabina Ariff, MBBS, FCPS||+92 21 34864357 ext firstname.lastname@example.org|
|Contact: Asghar Ali, MRA,MBA||92 213 493 0051 ext email@example.com|
|Dadu, Sindh, Pakistan|
|THQ Khairpur Nathan Shah||Recruiting|
|Dadu, Sindh, Pakistan|
|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|