Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants (KMC)
Primary Purpose
LBW, Preterm
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Kangaroo Mother Care
Standard Care
Sponsored by

About this trial
This is an interventional prevention trial for LBW focused on measuring effects, KMC, LBW, preterm, temperature, breastfeeding, secondary hospitals
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.
Sites / Locations
- Seema Hyderali
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kangaroo Mother Care
Standard Care
Arm Description
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.
Routine incubator or cot care with breastfeeding support from nurses as per policy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of Infection
frequency of presume sepsis and need for antibiotics.
length of stay
Total days in hospital during the recruitment period.
weight gain
After discharge observation for weight gain in Follow-up visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01776281
Brief Title
Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants
Acronym
KMC
Official Title
Effects of Kangaroo Mother Care Among LBW and Preterm Infants:A Randomized Control Trial in Karachi
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LBW, Preterm
Keywords
effects, KMC, LBW, preterm, temperature, breastfeeding, secondary hospitals
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kangaroo Mother Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Routine incubator or cot care with breastfeeding support from nurses as per policy.
Intervention Type
Behavioral
Intervention Name(s)
Kangaroo Mother Care
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Primary Outcome Measure Information:
Title
Breastfeeding outcomes
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of Infection
Description
frequency of presume sepsis and need for antibiotics.
Time Frame
1-2 weeks(During hospital stay)
Title
length of stay
Description
Total days in hospital during the recruitment period.
Time Frame
1-2 weeks
Title
weight gain
Description
After discharge observation for weight gain in Follow-up visit.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rozina Karmaliani, PhD
Organizational Affiliation
Aga Kahn University School of Nursing and Midwifery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zulfiqar Bhutta
Organizational Affiliation
AKUH
Official's Role
Study Director
Facility Information:
Facility Name
Seema Hyderali
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74500
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants
We'll reach out to this number within 24 hrs