Hospital-Based Paraprofessional Lactation Clinic

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00474422
First received: May 14, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

Hypothesis: We hypothesized that providing in-hospital, supervised paraprofessional breastfeeding consultation during the hiatus between hospital discharge and the first postpartum WIC or pediatric visit would increase the rate of exclusive breastfeeding among low income Hispanic women at 1 month postpartum.


Condition Intervention
Breastfeeding
Behavioral: Proactive assignment to attend a breastfeeding clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Hospital-Based Paraprofessional Lactation Clinic

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Percent of infants breastfed exclusively [ Time Frame: 4 weeks of age ]
  • Daily volume of formula supplement received by mixed feeders [ Time Frame: at 4 weeks of age ]

Secondary Outcome Measures:
  • Percent of infants receiving water, tea, or Agua de Arroz [ Time Frame: 4 weeks postpartum ]
  • Breastfeeding problems experienced [ Time Frame: in first month postpartum ]
  • Satisfaction with Hospital care [ Time Frame: 4 weeks postpartum ]
  • Maternal and Infant utilization of health care services [ Time Frame: during 1st month postpartum ]

Enrollment: 522
Study Start Date: December 2003
Study Completion Date: February 2005
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • intent to breastfeed
  • delivery at target hospital
  • Hispanic
  • mother and infant scheduled for joint discharge
  • healthy mother and infant

Exclusion Criteria:

infant at elevated risk for hyperbilirubinemia:

  • <37 weeks gestation at birth,
  • < 48 hours of age at discharge,
  • jaundice within 24 hours of birth,
  • Rh incompatibility; cephalohematoma,
  • positive coombs test,
  • family history of disorders of RBC enzyme defects or defects of RBC shape and size,
  • exclusive breastfeeding in the hospital
  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: NCT00474422

Locations
United States, Texas
Ben Taub General Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Judy M Hopkinson, PhD Baylor College of Medicine
  More Information

No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00474422     History of Changes
Other Study ID Numbers: MM-0723
Study First Received: May 14, 2007
Last Updated: May 14, 2007
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
breastfeeding
support

ClinicalTrials.gov processed this record on July 20, 2014