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NCT Number: NCT01776281

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

- 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.

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Key information

Conditions

LBW Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Urogenital Diseases

Age range

1 day–1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seema Hyderali

Karachi, Sindh, 74500, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kangaroo Mother Care

Behavioral

Standard Care

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of Infection

    Time frame: 1-2 weeks(During hospital stay)

    frequency of presume sepsis and need for antibiotics.

  2. length of stay

    Time frame: 1-2 weeks

    Total days in hospital during the recruitment period.

  3. weight gain

    Time frame: 30 days

    After discharge observation for weight gain in Follow-up visit.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Acronym: KMC

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2013
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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