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Feeding and Wellness Among Late Preterm Infants

University Hospitals (UH) logo

University Hospitals (UH)

Status

Completed

Conditions

Late Preterm Infant

Treatments

Procedure: Weekly telephone call

Study type

Interventional

Funder types

Other

Identifiers

NCT00470717
LF-UH-1001

Details and patient eligibility

About

  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.

Full 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.

Enrollment

38 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

Phone calling
Other group
Description:
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.
Treatment:
Procedure: Weekly telephone call

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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