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NCT Number: NCT00418106

Kangaroo Holding Effects on Breast Milk

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Hospital

Newark, Delaware, 19718, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Breast milk production and composition

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • University of Delaware

Registry information

Official study title

Early Kangaroo Holding Effects on Breast Milk Composition

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 4, 2007
Registry last updated
Jan 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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