Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470717
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2007-05-07
Brief Title:
Feeding and Wellness Among Late Preterm Infants
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Early Feeding and Wellness Among Late Preterm Infants Born at MacDonald Womens Hospital A Feasibility Study for a Breastfeeding Intervention
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 07- 36 67 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 Womens 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
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 Womens 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 07 - 36 67 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None