NCT03545204

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 The country has a high proportion of preterm births and according to unpublished data it ranges between 15-20% of all live births.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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

February 20, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

February 20, 2018

Last Update Submit

April 8, 2020

Conditions

Low-Birth-Weight Infant

Keywords

Community Kangaroo mother careLow birth weight

Outcome Measures

Primary Outcomes (1)

  • Neonatal mortality

    Primary outcome is to reduce 30% neonatal mortality in low birth weight babies (≥1200g - ≤2500g)

    2 years

Secondary Outcomes (5)

  • Exclusive breast feeding

    6 months of age

  • Growth monitoring through Anthropometric measures

    1, 3 and 6 months

  • Possible severe bacterial infection

    1st and 2nd months of age

  • Neurodevelopment assessment

    6, 9, 12 and 24 months

  • Cost-effectiveness of KMC implementation model

    2 years

Study Arms (2)

Intervention Clusters

OTHER

Community based Kangaroo Mother Care,KMC package in low birth weight infants of randomly selected union councils.

Other: Kangaroo Mother Care Package

Control clusters

OTHER

Essential newborn and routine standard care in low birth weight infants of randomly selected union councils.

Other: Routine Standard Care

Interventions

Kangaroo Mother Care PackageOTHER

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

Also known as: community KMC package
Intervention Clusters
Routine Standard CareOTHER

Routine Standard Care ( essential Newborn care )ENC

Control clusters

Eligibility Criteria

Age30 Minutes - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

THQ Johi

Dadu, Sindh, Pakistan

RECRUITING

THQ Khairpur Nathan Shah

Dadu, Sindh, Pakistan

RECRUITING

Related Publications (9)

  • Bergh AM, de Graft-Johnson J, Khadka N, Om'Iniabohs A, Udani R, Pratomo H, De Leon-Mendoza S. The three waves in implementation of facility-based kangaroo mother care: a multi-country case study from Asia. BMC Int Health Hum Rights. 2016 Jan 27;16:4. doi: 10.1186/s12914-016-0080-4.

    PMID: 26818943BACKGROUND

  • Vesel L, Bergh AM, Kerber KJ, Valsangkar B, Mazia G, Moxon SG, Blencowe H, Darmstadt GL, de Graft Johnson J, Dickson KE, Ruiz Pelaez J, von Xylander S, Lawn JE; KMC Research Acceleration Group. Kangaroo mother care: a multi-country analysis of health system bottlenecks and potential solutions. BMC Pregnancy Childbirth. 2015;15 Suppl 2(Suppl 2):S5. doi: 10.1186/1471-2393-15-S2-S5. Epub 2015 Sep 11.

    PMID: 26391115BACKGROUND

  • Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.

    PMID: 22579125BACKGROUND

  • Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.

    PMID: 22682464BACKGROUND

  • Lawn JE, Kerber K, Enweronu-Laryea C, Cousens S. 3.6 million neonatal deaths--what is progressing and what is not? Semin Perinatol. 2010 Dec;34(6):371-86. doi: 10.1053/j.semperi.2010.09.011.

    PMID: 21094412BACKGROUND

  • Lawn JE, Mwansa-Kambafwile J, Horta BL, Barros FC, Cousens S. 'Kangaroo mother care' to prevent neonatal deaths due to preterm birth complications. Int J Epidemiol. 2010 Apr;39 Suppl 1(Suppl 1):i144-54. doi: 10.1093/ije/dyq031.

    PMID: 20348117BACKGROUND

  • Conde-Agudelo A, Belizan JM, Diaz-Rossello J. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2011 Mar 16;(3):CD002771. doi: 10.1002/14651858.CD002771.pub2.

    PMID: 21412879BACKGROUND

  • Lima G, Quintero-Romero S, Cattaneo A. Feasibility, acceptability and cost of kangaroo mother care in Recife, Brazil. Ann Trop Paediatr. 2000 Mar;20(1):22-6. doi: 10.1080/02724930092020.

    PMID: 10824209BACKGROUND

  • Ariff S, Habib A, Memon Z, Arshad T, Samejo T, Maznani I, Umer M, Hussain A, Rizvi A, Ahmed I, Soofi SB, Bhutta ZA. Effect of Community-Based Kangaroo Mother Care Package on Neonatal Mortality Among Preterm and Low Birthweight Infants in Rural Pakistan: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2021 Aug 10;10(8):e28156. doi: 10.2196/28156.

    PMID: 34170839DERIVED

Related Links

Study Officials

  • Zulfiqar A Bhutta, FCPS, PhD

    Aga Khan University and Hospital

    STUDY CHAIR

  • Dr Sajid B Soofi, MBBS, FCPS

    Aga Khan University

    STUDY DIRECTOR

  • Dr Shabina Ariff, MBBS, FCPS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Shabina Ariff, MBBS, FCPS

CONTACT

+92 21 34864357shabina.ariff@aku.edu

Asghar Ali, MRA,MBA

CONTACT

92 213 493 0051asghar.ali@aku.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants,and outcome assessor will be masked about the intervention provided in the other arm.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 20, 2018

First Posted

June 4, 2018

Study Start

February 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2021

Last Updated

April 9, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)