Feeding and Wellness Among Late Preterm Infants - Full Text View

Sponsored by:	University Hospitals of Cleveland
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00470717

Purpose

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, we 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. We 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

MedlinePlus related topics: Breast Feeding

U.S. FDA Resources

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

Further study details as provided by University Hospitals of Cleveland:

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) ]

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) ]

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470717

Sponsors and Collaborators

University Hospitals of Cleveland

Investigators

Principal Investigator:

Lydia M Furman, M.D.

Case Western Reserve University School of Medicine

More Information

Study ID Numbers:	LF-UH-1001
Study First Received:	May 7, 2007
Last Updated:	May 7, 2007
ClinicalTrials.gov Identifier:	NCT00470717
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

late preterm infant
breastfeeding
formula feeding
rehospitalization
telephone

ClinicalTrials.gov processed this record on January 14, 2009