Feeding and Wellness Among Late Preterm Infants

NCT ID: NCT00470717

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-01-31

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.

Conditions

Late Preterm Infant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Phone calling

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.

Group Type: OTHER

Weekly telephone call

Intervention Type: PROCEDURE

Details of feeding and health/sickness will be obtained

Interventions

Weekly telephone call

Details of feeding and health/sickness will be obtained

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Age < 18 years, or per caregiver discretion mother is not appropriate for study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lydia Furman

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lydia M Furman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University School of Medicine

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

LF-UH-1001

Identifier Type: -

Identifier Source: org_study_id