NCT04638075

Supplemental Nursing System Compared to Bottle Supplementation

Use of Supplemental Nursing System Compared to Bottle Supplementation on Breastfeeding Rates in Hospitalized Neonates With Hyperbilirubinemia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 1 Day – 50 Years
• Healthy volunteers: Accepted

Summary

This is a randomized controlled trial comparing the SNS to bottle feeding. This study will compare exclusive breastfeeding rates and breast milk feeding rates at discharge, day of life 14, and day of life 28 between neonates hospitalized in the NICU for hyperbilirubinemia between those who receive supplementation by the (SNS) or those who receive supplementation by bottle. Additionally, this study will evaluate mothers' experiences while using the SNS. We hypothesize mothers who utilize the SNS will have higher rates of breast milk feeding compared to mothers who supplement by bottle.

Detailed description

Supplemental feedings in the neonatal intensive care unit (NICU) are common due to the separation of mother and neonate and/or complex medical issues that make direct breastfeeding difficult. The Supplemental Nursing System (SNS) is utilized infrequently in the NICU and there is little data available to compare breastfeeding outcomes of mothers who supplement by bottle compared to SNS. The aims of this study are to understand whether supplementation by SNS improves breastfeeding outcomes compared to neonates supplemented by bottle. From December 1, 2018 - November 30, 2019 there were 195 neonates admitted to Children's Hospital Colorado (CHCO) with a primary diagnosis of hyperbilirubinemia who were born at 37 weeks or greater. This makes up approximately 13.7% of all admissions during that time frame. This is a population of mothers at risk for cessation of exclusive breastfeeding due to the necessity of supplementation. These neonates are frequently supplemented because the mother's milk typically is not yet in to support adequate nutritional intake. These neonates are not often medically complex or have any factors that would bias the results of this study.

Conditions

• Breast Feeding, Exclusive

Interventions

Type	Name	Description
DEVICE	Supplemental Nursing System	The SNS is a device designed to deliver supplemental milk by suckling at the mother's nipple. A specially designed bottle attaches to the mother's breast and serves as the reservoir for milk. Attached to the bottle is a small tube which runs down to and is placed on the tip of the mother's nipple. With an adequate latch the neonate obtains supplementation by suckling. Additionally, this suckling stimulates milk production (Lawrence \& Lawrence, 2016).

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-11-20
• Last updated: 2022-05-12

Regulatory

• FDA-regulated device study