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Hospital-Based Paraprofessional Lactation Clinic

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00474422
First Posted: May 16, 2007
Last Update Posted: May 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
Baylor College of Medicine
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474422


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

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
First Submitted: May 14, 2007
First Posted: May 16, 2007
Last Update Posted: May 16, 2007
Last Verified: May 2007

Keywords provided by Baylor College of Medicine:
breastfeeding
support