NCT01776281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

5 months

First QC Date

January 22, 2013

Last Update Submit

January 25, 2013

Conditions

LBWPreterm

Keywords

effectsKMCLBWpretermtemperaturebreastfeedingsecondary hospitals

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Rate of Infection

    1-2 weeks(During hospital stay)

  • length of stay

    1-2 weeks

  • weight gain

    30 days

Study Arms (2)

Kangaroo Mother Care

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

Routine incubator or cot care with breastfeeding support from nurses as per policy.

Behavioral: Standard Care

Interventions

Kangaroo Mother CareBEHAVIORAL
Kangaroo Mother Care
Standard CareBEHAVIORAL
Standard Care

Eligibility Criteria

Age1 Day - 1 Week
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Any preterm neonates (\< 37 weeks of gestation by maternal dates)
  • Low birth weight infants less than 2500 gm.

You may not qualify if:

  • Infants with brain hemorrhage, congenital abnormalities.
  • Infants needed double phototherapy.
  • Mothers with severe depression, sickness with intensive care requirements. Mother who refused to participate. Mothers who delivered live multiple babies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seema Hyderali

Karachi, Sindh, 74500, Pakistan

Location

MeSH Terms

Conditions

Premature BirthBreast Feeding

Interventions

Kangaroo-Mother Care MethodStandard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Rozina Karmaliani, PhD

    Aga Kahn University School of Nursing and Midwifery

    STUDY DIRECTOR

  • Zulfiqar Bhutta

    AKUH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 28, 2013

Study Start

March 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

PA(1)