Late Preterm Infant
Conditions
Keywords
late preterm infant, breastfeeding, formula feeding, rehospitalization, telephone
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.
Interventions
PROCEDUREWeekly telephone call
Details of feeding and health/sickness will be obtained
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mothers of singleton LPT (late preterm, gestational age 34 0/7- 36 6/7 completed weeks) infants
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phone Call Completion Rate | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
One infant was withdrawn from the study due to an unexpectedly long hospital stay (\>13 weeks), yielding a total of 38 study infants.
Participants by arm
| Arm | Count |
|---|---|
| Phone Calling | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Phone Calling |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 26.8 years STANDARD_DEVIATION 6.1 |
| Region of Enrollment United States | 38 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
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: Time frame: 13 weeks (3 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phone Calling | Phone Call Completion Rate | Could not be reached with 4 calls over 13 weeks | 52 calls |
| Phone Calling | Phone Call Completion Rate | Reached with 2 calls over 13 weeks | 102 calls |
| Phone Calling | Phone Call Completion Rate | Reached with 3 or 4 calls over 13 weeks | 59 calls |
| Phone Calling | Phone Call Completion Rate | Reached with one call over 13 weeks | 194 calls |
| Phone Calling | Phone Call Completion Rate | Missing | 87 calls |