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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ms Seema Hyderali, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01776281
First received: January 22, 2013
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

- 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.


Condition Intervention Phase
LBW
Preterm
 Behavioral: Kangaroo Mother Care
Behavioral: Standard Care
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Effects of Kangaroo Mother Care Among LBW and Preterm Infants:A Randomized Control Trial in Karachi

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Breastfeeding outcomes [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 1-2 weeks(During hospital stay) ] [ Designated as safety issue: Yes ]
    frequency of presume sepsis and need for antibiotics.

  • length of stay [ Time Frame: 1-2 weeks ] [ Designated as safety issue: Yes ]
    Total days in hospital during the recruitment period.

  • weight gain [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    After discharge observation for weight gain in Follow-up visit.


Enrollment: 82
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kangaroo Mother Care
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
Active Comparator: Standard Care
Routine incubator or cot care with breastfeeding support from nurses as per policy.
 Behavioral: Standard Care

  Eligibility

Ages Eligible for Study:   up to 1 Week
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776281

Locations
Pakistan
Seema Hyderali
Karachi, Sindh, Pakistan, 74500
Sponsors and Collaborators
Aga Khan University
Investigators
Study Director: Rozina Karmaliani, PhD Aga Kahn University School of Nursing and Midwifery
Study Director: Zulfiqar Bhutta AKUH
  More Information

No publications provided

Responsible Party: Ms Seema Hyderali, Student, Aga Khan University
ClinicalTrials.gov Identifier: NCT01776281     History of Changes
Other Study ID Numbers: SHyderali
Study First Received: January 22, 2013
Last Updated: January 25, 2013
Health Authority: Pakistan:AgaKhanU

Keywords provided by Aga Khan University:
effects
KMC
LBW
preterm
 temperature
breastfeeding
secondary hospitals

ClinicalTrials.gov processed this record on June 18, 2013