Feeding and Wellness Among Late Preterm Infants
- 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.
- 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.
|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|
- 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 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 ]
|Study Start Date:||November 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Procedure: Weekly telephone call
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470717
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Lydia M Furman, M.D.||Case Western Reserve University School of Medicine|