Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Feeding and Wellness Among Late Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT00470717
First received: May 7, 2007
Last updated: December 27, 2010
Last verified: December 2010
  Purpose
  1. The first aim of this proposal is to pilot the feasibility of weekly phone monitoring of infant feeding and illness patterns in a socio-economically and racially diverse population. Specifically, the investigators aim to estimate the rate of group loss to follow up from birth to 13 weeks (3 months) of age with weekly phone interview of mothers of late preterm (LPT, gestational age 34 0/7- 36 6/7 weeks gestation) infants.
  2. The second aim is to describe breastfeeding and formula feeding practices, and rates of illness and post-discharge hospital care utilization, through age 13 weeks (3 months) among late preterm infants born at MacDonald Women's Hospital. The investigators estimate that the rate of exclusive breastfeeding among LPT infants at 3 months of age is less than the documented rate of 37% for all infants in Cuyahoga County.

Condition Intervention
Infant, Premature
Morbidity
Procedure: Weekly telephone call

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Feeding and Wellness Among Late Preterm Infants Born at MacDonald Women's Hospital: A Feasibility Study for a Breastfeeding Intervention

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • The primary outcome measure will be the response rate for phone interview, including total calls made and interviews completed. [ Time Frame: Time frame: 13 weeks (3 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures include (1) rates of partial and exclusive breastfeeding each week , and (2) rates of illness, re-hospitalization and preventive health care [ Time Frame: Time frame: 13 weeks (3 months) ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Weekly telephone call
    Details of feeding and health/sickness will be obtained
Detailed Description:

Late preterm infants (LPT, gestational age 34 0/7 - 36 6/7 weeks) are the largest proportion of all preterm (less than 37 weeks gestation) infants. Recent evidence finds an increased risk of early post-discharge morbidity and re-hospitalization among LPT as compared to full term infants, which is linked to breastfeeding, specifically to early lactation failure and decreased breast milk intake. Accurate and inexpensive methods to collect data on rates of breastfeeding and early morbidity among LPT infants are critical to design, implementation and monitoring of effective interventions. This pilot study evaluates the feasibility of weekly phone calling in a racially and socioeconomically diverse population of mothers of LPT infants.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mothers of singleton LPT (late preterm, gestational age 34 0/7- 36 6/7 completed weeks) infants

Exclusion Criteria:

  • Exclusion criteria for mothers include positive maternal drug screen for drug of abuse
  • Age < 18 years, or per caregiver discretion mother is not appropriate for study.
  • Exclusion criteria for infants include custody under contention, positive screen for maternal drugs of abuse, or major congenital anomaly or congenital infection.
  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: NCT00470717

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
Investigators
Principal Investigator: Lydia M Furman, M.D. Case Western Reserve University School of Medicine
  More Information

No publications provided

Responsible Party: Lydia Furman, M.D., Rainbow Babies and Children's Hospital
ClinicalTrials.gov Identifier: NCT00470717     History of Changes
Other Study ID Numbers: LF-UH-1001
Study First Received: May 7, 2007
Last Updated: December 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
late preterm infant
breastfeeding
formula feeding
rehospitalization
telephone

ClinicalTrials.gov processed this record on November 25, 2014