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

Preterm Clinical Trial

— KMC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776281
• Other study ID #: SHyderali
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2013
• Last updated: January 25, 2013
• Start date: March 2012
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan:AgaKhanU
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Week

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• LBW
• Premature Birth
• Preterm

Intervention

Behavioral:
• Kangaroo Mother Care

• Standard Care

Locations

Country	Name	City	State
Pakistan	Seema Hyderali	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Rate of Infection	frequency of presume sepsis and need for antibiotics.	1-2 weeks(During hospital stay)	Yes
Secondary	length of stay	Total days in hospital during the recruitment period.	1-2 weeks	Yes
Secondary	weight gain	After discharge observation for weight gain in Follow-up visit.	30 days	Yes