Supplemental Nursing System Compared to Bottle Supplementation

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Feeding, Exclusive
• Intervention / Treatment: Device: Supplemental Nursing System

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Group A Bottle Supplementation; 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.
EXPERIMENTAL: Group B SNS Supplementation; 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Breastfeeding During Hospitalization	The Daily Feeding Log measures the frequency and duration of breastfeeding.	The Daily Feeding Log measures breastfeeding rates from within 12 hours after hospital admission to discharge, an average of 3 days.
Rate of Exclusive Breastfeeding at 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.	The rate of exclusive breastfeeding is measured from hospital discharge to day of life 14.
Rate of Exclusive Breastfeeding at 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.	The rate of exclusive breastfeeding is measured from day of life 14 to day of life 28.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Christine Bonavita, BSN, Colorado University

Publications and helpful links

General Publications

• Bar S, Milanaik R, Adesman A. Long-term neurodevelopmental benefits of breastfeeding. Curr Opin Pediatr. 2016 Aug;28(4):559-66. doi: 10.1097/MOP.0000000000000389.
• Bertini G, Dani C, Tronchin M, Rubaltelli FF. Is breastfeeding really favoring early neonatal jaundice? Pediatrics. 2001 Mar;107(3):E41. doi: 10.1542/peds.107.3.e41.
• Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.
• Borucki LC. Breastfeeding mothers' experiences using a supplemental feeding tube device: finding an alternative. J Hum Lact. 2005 Nov;21(4):429-38. doi: 10.1177/0890334405277822.
• Chaturvedi P. Relactation. Indian Pediatr. 1994 Jul;31(7):858-60.
• Cheales-Siebenaler NJ. Induced lactation in an adoptive mother. J Hum Lact. 1999 Mar;15(1):41-3. doi: 10.1177/089033449901500111.
• Flaherman VJ, Maisels MJ; Academy of Breastfeeding Medicine. ABM Clinical Protocol #22: Guidelines for Management of Jaundice in the Breastfeeding Infant 35 Weeks or More of Gestation-Revised 2017. Breastfeed Med. 2017 Jun;12(5):250-257. doi: 10.1089/bfm.2017.29042.vjf. Epub 2017 Apr 10. No abstract available.
• Howard CR, Howard FM, Lanphear B, Eberly S, deBlieck EA, Oakes D, Lawrence RA. Randomized clinical trial of pacifier use and bottle-feeding or cupfeeding and their effect on breastfeeding. Pediatrics. 2003 Mar;111(3):511-8. doi: 10.1542/peds.111.3.511.
• Seema, Patwari AK, Satyanarayana L. Relactation: an effective intervention to promote exclusive breastfeeding. J Trop Pediatr. 1997 Aug;43(4):213-6. doi: 10.1093/tropej/43.4.213.
• Lodge CJ, Bowatte G, Matheson MC, Dharmage SC. The Role of Breastfeeding in Childhood Otitis Media. Curr Allergy Asthma Rep. 2016 Sep;16(9):68. doi: 10.1007/s11882-016-0647-0.
• Lawrence, R, Lawrence, R (2016) Breastfeeding A Guide for The Medical Professional. Eighth Edition

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (ACTUAL): November 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Supplemental Nursing System
• Other Study ID Numbers: 20-0185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This data will be maintained at Children's Hospital Colorado only at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes