NCT00474422

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
522

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2003

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
Last Updated

June 28, 2022

Status Verified

May 1, 2007

First QC Date

May 14, 2007

Last Update Submit

June 23, 2022

Conditions

Breastfeeding

Keywords

breastfeedingsupport

Outcome Measures

Primary Outcomes (2)

  • Percent of infants breastfed exclusively

    4 weeks of age

  • Daily volume of formula supplement received by mixed feeders

    at 4 weeks of age

Secondary Outcomes (4)

  • Percent of infants receiving water, tea, or Agua de Arroz

    4 weeks postpartum

  • Breastfeeding problems experienced

    in first month postpartum

  • Satisfaction with Hospital care

    4 weeks postpartum

  • Maternal and Infant utilization of health care services

    during 1st month postpartum

Interventions

Proactive assignment to attend a breastfeeding clinicBEHAVIORAL

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Hopkinson J, Konefal Gallagher M. Assignment to a hospital-based breastfeeding clinic and exclusive breastfeeding among immigrant Hispanic mothers: a randomized, controlled trial. J Hum Lact. 2009 Aug;25(3):287-96. doi: 10.1177/0890334409335482. Epub 2009 May 12.

    PMID: 19436060DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Judy M Hopkinson, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Center Director and Professor

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 16, 2007

Study Start

December 1, 2003

Study Completion

February 1, 2005

Last Updated

June 28, 2022

Record last verified: 2007-05

Locations

US(1)