Clinical trial NCT04638075: Supplemental Nursing System Compared to Bottle Supplementation
Official title: Use of Supplemental Nursing System Compared to Bottle Supplementation on Breastfeeding Rates in Hospitalized Neonates With Hyperbilirubinemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Feeding, Exclusive
Keywords: Supplemental Nursing System
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial comparing the SNS to bottle feeding. Once eligibility is determined and consent is obtained, the Primary Investigator (PI)/ Co-Investigator (CI) will randomize the mother-neonate dyad to either bottle supplemental feedings (group A) or SNS supplemental feedings (group B). Randomization will be done by using a computer-generated table of random numbers. Breast milk feeding and exclusive breastfeeding rates will be compared between both groups during the last 24 hours of hospitalization, at day of life 14 and at day of life 28.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Rate of Breastfeeding During Hospitalization
timeFrame: The Daily Feeding Log measures breastfeeding rates from within 12 hours after hospital admission to discharge, an average of 3 days.
measure: Rate of Exclusive Breastfeeding at Day of Life 14.
timeFrame: The rate of exclusive breastfeeding is measured from hospital discharge to day of life 14.
measure: Rate of Exclusive Breastfeeding at Day of Life 28.
timeFrame: The rate of exclusive breastfeeding is measured from day of life 14 to day of life 28.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Colorado University
name: Christine Bonavita, BSN
role: PRINCIPAL_INVESTIGATOR
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