search
Back to results

Feeding and Wellness Among Late Preterm Infants

Primary Purpose

Late Preterm Infant

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekly telephone call
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Late Preterm Infant focused on measuring late preterm infant, breastfeeding, formula feeding, rehospitalization, telephone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Phone calling

Arm 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.

Outcomes

Primary Outcome Measures

Phone Call Completion Rate
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.

Secondary Outcome Measures

Full Information

First Posted
May 7, 2007
Last Updated
September 29, 2021
Sponsor
University Hospitals Cleveland Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00470717
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Late Preterm Infant
Keywords
late preterm infant, breastfeeding, formula feeding, rehospitalization, telephone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phone calling
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Weekly telephone call
Intervention Description
Details of feeding and health/sickness will be obtained
Primary Outcome Measure Information:
Title
Phone Call Completion Rate
Description
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.
Time Frame
Time frame: 13 weeks (3 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia M Furman, M.D.
Organizational Affiliation
Case Western Reserve University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Feeding and Wellness Among Late Preterm Infants

We'll reach out to this number within 24 hrs