NCT00418106

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2005

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

November 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
Last Updated

January 18, 2008

Status Verified

January 1, 2008

Enrollment Period

1.1 years

First QC Date

January 2, 2007

Last Update Submit

January 16, 2008

Conditions

Premature Birth

Keywords

Premature birthPumping breast milkKangaroo holding

Outcome Measures

Primary Outcomes (1)

  • Breast milk production and composition

    1 week

Study Arms (1)

1

Mothers who are pumping breast milk and who are willing to kangaroo hold their infant.

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Mothers of preterm infants

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Amy N. Johnson, DNSc, RNC

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

November 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

January 18, 2008

Record last verified: 2008-01

Locations

US(1)