An interventional study of Specialized Preterm Infant/Mother Dyad Lactation Support in Breastfeeding, sponsored by Medical University of South Carolina. Completed. Per ClinicalTrials.gov, last updated 2018-06-13.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether a post-hospital discharge lactation support system increases preterm infant intake of mother's milk.
Preterm infants have barriers to successful breastfeeding that include oral feeding immaturity and high nutritional needs. Therefore, successful preterm infant breastfeeding requires increased counseling and equipment support compared to full-term infant breastfeeding. Inpatient preterm infant care has responded to these barriers, with specialized preterm infant lactation support. Unfortunately, for preterm infants, the onset of feeding maturity often coincides with hospital discharge and, therefore, inpatient, specialized lactation support ends just as the infant initiates nutritive feeding at the breast. Therefore, the success of preterm infant breastfeeding relies on the home environment and the community pediatric caregivers. A program has been created to provide this specialized preterm infant/mother outpatient lactation support. The program includes in-home availability of a hospital-grade electric pump and an infant weigh scale and pediatric clinic-based lactation counseling support. Fourteen pediatric practices are included in this study. Seven practices were randomized to intervention and seven were randomized to be controls.
Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For infants receiving pediatric care at one of the seven intervention practices, mothers will receive the Specialized Preterm Infant/Mother Dyad Lactation Support which includes home equipment and pediatric clinic-lactation support to support lactation for four months post-hospital discharge.
Other: Specialized Preterm Infant/Mother Dyad Lactation Support
For infants receiving pediatric care at one of the seven control practices, mothers will receive standard support.
Mother will receive home equipment and pediatric clinic lactation support.
Preterm infant intake of mother's milk post-hospital discharge measured by survey.
Time frame: 4 months
Preterm infant breastfeeding post-hospital discharge measured by survey.
Time frame: 4 months
Sustaining preterm infant mother's milk intake post-hospital discharge measured by survey.
Time frame: 6 months
Preterm infant growth post-hospital discharge collected from pediatric clinic medical record.
Time frame: 6 months
Preterm infant re-hospitalization post-hospital discharge collected from pediatric clinic medical record.
Time frame: 6 months
Preterm infant respiratory illness events post-hospital discharge collected from pediatric clinic medical record.
Time frame: 6 months
Preterm infant gastrointestinal illness events post-hospital discharge collected from pediatric clinic medical record.
Time frame: 6 months
No study locations are listed for this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina