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Clinical Trials/NCT00418106
NCT00418106CompletedNot Applicable

Early Kangaroo Holding Effects on Breast Milk Composition

Christiana Care Health Services1 site in 1 country20 target enrollmentStarted: November 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Breast milk production and composition

Study Overview

Brief Summary

Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have investigated the maternal and infant benefits associated with kangaroo holding. The purpose of this study is to determine if kangaroo holding a baby changes the amount and composition of breast milk pumped before and after the kangaroo holding session.

Hypotheses:

  1. There is a significant difference in volume of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding conditions
  2. There is a significant difference in the composition of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding condition.

Detailed Description

This study will address two of the overwhelming challenges in the physiologic care of premature infants in the neonatal intensive care unit (NICU) environment. The first challenge is promoting neonatal growth through providing a careful balance of nutrition to caloric expenditure for premature infants. The second challenge is supporting parents in the intensive, technology driven environment of the NICU to merge physiologic care with parental-infant interaction through touch, communication, and maternal intervention. The vast majority of mothers with premature infants express breast milk for early feedings, however milk production tends to diminish three to four weeks after delivery. The practice of skin-to-skin holding is thought to promote the mother's ability to produce breast milk, but had not been empirically tested. This study will examine the relationship of kangaroo holding on mother's breast milk production and composition.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 14 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Birth weight </= 2000 grams
  • Gestational age 26-34 weeks at birth
  • Medically stable at start of study
  • < 14 days old at start of study

Exclusion Criteria

  • Infants receiving phototherapy
  • Suspected congenital abnormalities
  • Overwhelming sepsis
  • Cardiac Abnormalities
  • Suspected infections

Outcomes

Primary Outcomes

Breast milk production and composition

Time Frame: 1 week

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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