Supplemental Nursing System Compared to Bottle Supplementation

University of Colorado Denver (CU Denver)

Status: Withdrawn

Conditions: Breast Feeding, Exclusive

Treatments: Device: Supplemental Nursing System

Study type: Interventional

Funder types: Other

Identifiers

NCT04638075

20-0185

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 day to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group A Bottle Supplementation

No Intervention group

Description:

Group A will supplement using the bottle. The mother will breastfeed as frequently as the neonate's physician allows. When the physician recommends supplementation, the mother will supplement using the bottle per standard of care. The mother will breastfeed for up to 25 minutes and then will offer a bottle to supplement breastfeeding for at least 5 minutes. Time at the breast and with the bottle might vary based on the neonate's ability to stay awake at the breast and to sustain a latch at the breast. The type of supplementation will be either Expressed Breast Milk (EBM), Donor Human Milk (DHM), formula, or a combination of EBM and formula or EBM and DHM. The volume of supplementation and duration of bottle use will be determined by the neonate's physician. The mother will return the neonate to their crib then pump and hand express after feeding sessions per the IBCLC's recommendation. The mother will document each feeding session in the feeding log provided at the bedside.

Group B SNS Supplementation

Experimental group

Description:

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.

Treatment:

Device: Supplemental Nursing System