Feeding and Wellness Among Late Preterm Infants

Not Applicable

Completed

• Conditions: Late Preterm Infant
• Interventions: Procedure: Weekly telephone call

• Registration Number: NCT00470717
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Study Timeline

• Study First Submitted: 2007-05-07
• Study First Submitted QC: 2007-05-07
• Study First Posted: 2007-05-08
• Study Start: 2008-11
• Primary Completion: 2009-02
• Study Completion: 2010-01
• Results First Submitted: 2018-10-31
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Results First Posted: 2021-10-01
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phone calling	Weekly telephone call	Weekly telephone call. There are not two arms to the study. The primary intervention is phone calling weekly to assess ability to complete phone call and obtain feeding data.

Primary Outcome Measures

Name	Time	Method
Phone Call Completion Rate	Time frame: 13 weeks (3 months)	Phone call Completion is defined as the phone call was answered by the participant and information was obtained on the survey measures. Phone call completion rate is the number of calls completed over the study period.

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States