Clinical trial NCT00470717: Feeding and Wellness Among Late Preterm Infants
Official title: Early Feeding and Wellness Among Late Preterm Infants Born at MacDonald Women's Hospital: A Feasibility Study for a Breastfeeding Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Late Preterm Infant
Keywords: late preterm infant
breastfeeding
formula feeding
rehospitalization
telephone
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2007-05-08
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Phone Call Completion Rate
timeFrame: Time frame: 13 weeks (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University School of Medicine
name: Lydia M Furman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: