- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00418106
Kangaroo Holding Effects on Breast Milk
January 16, 2008 updated by: Christiana Care Health Services
Early Kangaroo Holding Effects on Breast Milk Composition
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:
- 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
- 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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
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Newark, Delaware, United States, 19718
- Christiana Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Mothers of preterm infants
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
1
Mothers who are pumping breast milk and who are willing to kangaroo hold their infant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Breast milk production and composition
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy N. Johnson, DNSc, RNC, Christiana Care Health Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
January 2, 2007
First Submitted That Met QC Criteria
January 2, 2007
First Posted (Estimate)
January 4, 2007
Study Record Updates
Last Update Posted (Estimate)
January 18, 2008
Last Update Submitted That Met QC Criteria
January 16, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24211
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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