Kangaroo Holding Effects on Breast Milk

This study has been completed.
Sponsor:
Collaborator:
University of Delaware
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00418106
First received: January 2, 2007
Last updated: January 16, 2008
Last verified: January 2008
  Purpose

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.

Condition
Premature Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Kangaroo Holding Effects on Breast Milk Composition

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Breast milk production and composition [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Mothers who are pumping breast milk and who are willing to kangaroo hold their infant.

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.

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Mothers of preterm infants

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418106

Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
University of Delaware
Investigators
Principal Investigator: Amy N. Johnson, DNSc, RNC Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Amy N. Johnson, DNSc, RN, Christiana Hospital
ClinicalTrials.gov Identifier: NCT00418106     History of Changes
Other Study ID Numbers: 24211
Study First Received: January 2, 2007
Last Updated: January 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Premature birth
Pumping breast milk
Kangaroo holding

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 23, 2014