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

Study Overview
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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.

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

Conditions
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LBW, Preterm

Intervention / Treatment
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* Behavioral: Kangaroo Mother Care
* Behavioral: Standard Care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Week

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kangaroo Mother Care<br>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<br> <br> |
| Active Comparator: Standard Care<br>Routine incubator or cot care with breastfeeding support from nurses as per policy. | Behavioral: Standard Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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effects, KMC, LBW, preterm, temperature, breastfeeding, secondary hospitals