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

NCT ID: NCT01776281

Last Updated: 2013-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-08-31

Brief Summary

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\- 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

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Conditions

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LBW Preterm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Kangaroo Mother Care

Intervention Type BEHAVIORAL

Standard Care

Routine incubator or cot care with breastfeeding support from nurses as per policy.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Interventions

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Kangaroo Mother Care

Intervention Type BEHAVIORAL

Standard Care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Ms Seema Hyderali

Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rozina Karmaliani, PhD

Role: STUDY_DIRECTOR

Aga Kahn University School of Nursing and Midwifery

Zulfiqar Bhutta

Role: STUDY_DIRECTOR

AKUH

Locations

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Seema Hyderali

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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SHyderali

Identifier Type: -

Identifier Source: org_study_id

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