Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants (KMC)

January 25, 2013 updated by: Ms Seema Hyderali, Aga Khan University

Effects of Kangaroo Mother Care Among LBW and Preterm Infants:A Randomized Control Trial in Karachi

- Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of deaths among premature and low birth weight LBW infants. Even if the infants are born in facilities, incidences of cold stress are possible due to insufficient resources, space and incompetent practices to manage hypothermia in the immediate postnatal period. Kangaroo Mother Care is a well-known intervention to address the issues related to preterm births, such as hypothermia, infection and prolong hospitalization.Besides significant outcome of KMC interventions for preterm infants, no interventional study has been found in literature in Pakistani context. Looking at the potential benefits of KMC in reducing the related complications of prematurity, the study aims to identify the effectiveness of KMC among preterm and LBW infants born in secondary hospital of Aga khan University hospitals.

Hypothesis I Ha: KMC is effective in reducing the incidences of hypothermia among preterm and LBW infants as compared to the usual care.

Hypothesis II Ha: There is a difference in breastfeeding behavior and breastfeeding outcome among experimental and control group.

Secondary Hypothesis Hypothesis I Ha: There is an association between KMC and frequency of suspected infections during hospitalization.

Hypothesis II Ha: There is a difference in length of stay among experimental group and control group.

Hypothesis III Ha: There is a relationship between KMC and weight gain of infants till four weeks.

Hypothesis IV Ha: There is difference in rate of hypothermia among experimental group and control after discharge from hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74500
        • Seema Hyderali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any preterm neonates (< 37 weeks of gestation by maternal dates)
  • Low birth weight infants less than 2500 gm.

Exclusion Criteria:

  • Infants with brain hemorrhage, congenital abnormalities.
  • Infants needed double phototherapy.

Exclusion of Mother:

Mothers with severe depression, sickness with intensive care requirements. Mother who refused to participate. Mothers who delivered live multiple babies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Kangaroo Mother Care
Other than routine clinical care per hospital policy. Infants will receive skin-to-skin contact for minimum one hour daily during hospital stay and at home till one month.
Behavioral: Kangaroo Mother Care
ACTIVE_COMPARATOR: Standard Care
Routine incubator or cot care with breastfeeding support from nurses as per policy.
Behavioral: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding outcomes
Time Frame: 30 days

Comparison of breastfeeding frequency per day, method of feeding. (partial/ exclusive)in hospital and at home.

Breastfeeding behaviour by using preterm Infants breastfeeding behaviour Scale(PIBBS).

Follow-up till one months by calling and record keeping of breastfeeding status.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Infection
Time Frame: 1-2 weeks(During hospital stay)
frequency of presume sepsis and need for antibiotics.
1-2 weeks(During hospital stay)
length of stay
Time Frame: 1-2 weeks
Total days in hospital during the recruitment period.
1-2 weeks
weight gain
Time Frame: 30 days
After discharge observation for weight gain in Follow-up visit.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Study Director: Rozina Karmaliani, PhD, Aga Kahn University School of Nursing and Midwifery
  • Study Director: Zulfiqar Bhutta, AKUH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (ESTIMATE)

January 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHyderali

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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