Trial Outcomes & Findings for Feeding and Wellness Among Late Preterm Infants (NCT NCT00470717)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Time frame: 13 weeks (3 months)

Results posted on

2021-10-01

Participant Flow

Of 84 inborn LPT infants admitted, 68 (81%) were eligible of whom 39 (57%) agreed to participate, 27 declined and 2 were missed due to brief hospital stays. Sixteen were ineligible: teen mother (7), major congenital malformation (3), positive maternal toxicology screen (2), custody uncertain/other reason (4).

One infant was withdrawn from the study due to an unexpectedly long hospital stay (\>13 weeks), yielding a total of 38 study infants.

Unit of analysis: phone call attempts

Participant milestones

Participant milestones
Measure	Phone Calling Weekly telephone call. There are not two arms to the study. The primary intervention was phone calling weekly to assess ability to complete phone call and obtain feeding data. Weekly telephone call: Details of feeding and health/sickness were obtained
Overall Study STARTED	38 1976
Overall Study COMPLETED	38 813
Overall Study NOT COMPLETED	0 1163

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feeding and Wellness Among Late Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phone Calling n=38 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26.8 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phone Calling n=494 phone call Weekly telephone call. There are not two arms to the study. The primary intervention was phone calling weekly to assess ability to complete phone call and obtain feeding data. Weekly telephone call: Details of feeding and health/sickness were obtained
Phone Call Completion Rate Reached with one call over 13 weeks	194 calls
Phone Call Completion Rate Reached with 2 calls over 13 weeks	102 calls
Phone Call Completion Rate Reached with 3 or 4 calls over 13 weeks	59 calls
Phone Call Completion Rate Could not be reached with 4 calls over 13 weeks	52 calls
Phone Call Completion Rate Missing	87 calls

Adverse Events

Phone Calling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Phone Calling n=38 participants at risk 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. Weekly telephone call: Details of feeding and health/sickness will be obtained
General disorders loss of confidentiality	0.00% 0/38

Additional Information

Dr. Lydia Furman

UHClevelandMC

Phone: 216-844-8260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place