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Supplemental Nursing System Compared to Bottle Supplementation

NCT04638075 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-05-12

No results posted yet for this study

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.

Conditions

  • Breast Feeding, Exclusive

Interventions

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).

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Christine Bonavita, BSN · Colorado University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638075 on ClinicalTrials.gov