Supplemental Nursing System Compared to Bottle Supplementation

Not Applicable

Withdrawn

• Conditions: Breast Feeding, Exclusive
• Interventions: Device: Supplemental Nursing System

• Registration Number: NCT04638075
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Study Start: 2022-01-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-12
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Neonate inclusion criteria: physician diagnosis of hyperbilirubinemia, otherwise healthy term neonates (gestational age 38 weeks +), appropriate size for gestation, and good latch to mother's nipple, with some consistent suckling behavior per standard assessment.

Maternal inclusion criteria: English or Spanish Speaking (with the use of medical interpreter), 18 years of age or greater, desire to exclusively breast milk feed, and must be available at the bedside for all feeding sessions during hospitalization.

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Exclusion Criteria

• Neonate exclusion criteria: Breast milk jaundice, and any condition that prevents the neonate from breastfeeding efficiently including anatomical abnormalities (cleft lip, cleft palate), neurological impairment, symptomatic hypoglycemia, newly diagnosed infections, cardiac anomalies, and intravenous fluid hydration.

Maternal exclusion criteria: Retained placenta, history of breast reduction surgery or breast radiation, physician diagnosed Sheehan's Syndrome, known hypoplastic breast tissue with a low supply after previous deliveries.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B SNS Supplementation	Supplemental Nursing System	Group B will supplement using the SNS. The mother will breastfeed as frequently as the neonate's physician allows. When the physician recommends supplementation, the mother will supplement using the SNS per standard of care. The mother will assemble the SNS, place it clamped and in position at the nipple prior to breastfeeding (see SNS instructions for use). The mother will initiate breastfeeding for up to 5 minutes and then unclamp the SNS to begin supplementation for up to 25 minutes. The SNS will contain either EBM, DHM, formula, or a combination of EBM and formula or EBM and DHM. The volume of supplementation and duration of SNS use will be determined by the neonate's physician. The mother will pump and hand express after feeding sessions per the IBCLC's recommendation. Them mother will document each feeding session in the feeding log provided at the bedside.

Primary Outcome Measures

Name	Time	Method
Rate of Breastfeeding During Hospitalization	The Daily Feeding Log measures breastfeeding rates from within 12 hours after hospital admission to discharge, an average of 3 days.	The Daily Feeding Log measures the frequency and duration of breastfeeding.
Rate of Exclusive Breastfeeding at Day of Life 14.	The rate of exclusive breastfeeding is measured from hospital discharge to day of life 14.	A survey is sent out at day of life 14 with a yes/no maternal response to a question asking if mother is exclusively breastfeeding.
Rate of Exclusive Breastfeeding at Day of Life 28.	The rate of exclusive breastfeeding is measured from day of life 14 to day of life 28.	A survey is sent out at day of life 28 with a yes/no maternal response to a question asking if mother is exclusively breastfeeding.