Clinical trial NCT01776281: Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants
Official title: Effects of Kangaroo Mother Care Among LBW and Preterm Infants:A Randomized Control Trial in Karachi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: LBW
Preterm
Keywords: effects
KMC
LBW
preterm
temperature
breastfeeding
secondary hospitals
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Breastfeeding outcomes
timeFrame: 30 days
Secondary outcomes:
measure: Rate of Infection
timeFrame: 1-2 weeks(During hospital stay)
measure: length of stay
timeFrame: 1-2 weeks
measure: weight gain
timeFrame: 30 days
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Seema Hyderali
state: Sindh
Study officials:
affiliation: Aga Kahn University School of Nursing and Midwifery
name: Rozina Karmaliani, PhD
role: STUDY_DIRECTOR
affiliation: AKUH
name: Zulfiqar Bhutta
role: STUDY_DIRECTOR
References: