Kangaroo Holding Effects on Breast Milk

Premature Birth Clinical Trial

Official title:

Early Kangaroo Holding Effects on Breast Milk Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418106
• Other study ID #: 24211
• Status: Completed
• Phase: N/A
• First received: January 2, 2007
• Last updated: January 16, 2008
• Start date: November 2005
• Est. completion date: December 2006

Study information

• Verified date: January 2008
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth

Locations

Country	Name	City	State
United States	Christiana Hospital	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast milk production and composition		1 week	No