Supplemental Nursing System Compared to Bottle Supplementation

NCT04638075 | Withdrawn FDA Device

• 1 other identifier: 20-0185
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Feeding, Exclusive

Keywords

Supplemental Nursing System

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Group A Bottle Supplementation

NO INTERVENTION

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 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

Interventions

Supplemental Nursing System DEVICE

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).

Group B SNS Supplementation

Eligibility Criteria

• Age: 1 Day - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Related Publications (11)

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  PMID: 27386975 BACKGROUND

• 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.

  PMID: 11230622 BACKGROUND

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  PMID: 26792873 BACKGROUND

• 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.

  PMID: 16280559 BACKGROUND

• Chaturvedi P. Relactation. Indian Pediatr. 1994 Jul;31(7):858-60.

  PMID: 7890356 BACKGROUND

• Cheales-Siebenaler NJ. Induced lactation in an adoptive mother. J Hum Lact. 1999 Mar;15(1):41-3. doi: 10.1177/089033449901500111.

  PMID: 10578774 BACKGROUND

• 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.

  PMID: 29624434 BACKGROUND

• 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.

  PMID: 12612229 BACKGROUND

• 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.

  PMID: 9283123 BACKGROUND

• 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.

  PMID: 27595154 BACKGROUND

• Lawrence, R, Lawrence, R (2016) Breastfeeding A Guide for The Medical Professional. Eighth Edition

  BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Christine Bonavita, BSN

  Colorado University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: November 20, 2020
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share