NCT00470717

Brief Summary

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2007

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
11.8 years until next milestone

Results Posted

Study results publicly available

October 1, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

May 7, 2007

Results QC Date

October 31, 2018

Last Update Submit

September 29, 2021

Conditions

Keywords

late preterm infantbreastfeedingformula feedingrehospitalizationtelephone

Outcome Measures

Primary Outcomes (1)

  • 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.

    Time frame: 13 weeks (3 months)

Study Arms (1)

Phone calling

OTHER

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.

Procedure: Weekly telephone call

Interventions

Details of feeding and health/sickness will be obtained

Phone calling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Results Point of Contact

Title
Dr. Lydia Furman
Organization
UHClevelandMC

Study Officials

  • Lydia M Furman, M.D.

    Case Western Reserve University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 8, 2007

Study Start

November 1, 2008

Primary Completion

February 1, 2009

Study Completion

January 1, 2010

Last Updated

October 1, 2021

Results First Posted

October 1, 2021

Record last verified: 2021-09

Locations