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

Phase 2

Completed

• Conditions: Preterm; LBW
• Interventions: Behavioral: Standard Care; Behavioral: Kangaroo Mother Care

• Registration Number: NCT01776281
• Lead Sponsor: Aga Khan University

Brief Summary

- 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-25
• Last Update Submitted: 2013-01-25
• Study First Posted: 2013-01-28
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Routine incubator or cot care with breastfeeding support from nurses as per policy.
Kangaroo Mother Care	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.

Primary Outcome Measures

Name	Time	Method
Breastfeeding outcomes	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seema Hyderali; 🇵🇰 Karachi, Sindh, Pakistan