Supplemental Nursing System Compared to Bottle Supplementation

Breast Feeding, Exclusive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04638075
• Other study ID #: 20-0185
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Feeding, Exclusive

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

References & Publications (11)

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. Review. — View Citation

Bertini G, Dani C, Tronchin M, Rubaltelli FF. Is breastfeeding really favoring early neonatal jaundice? Pediatrics. 2001 Mar;107(3):E41. — View Citation

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. Review. — View Citation

Borucki LC. Breastfeeding mothers' experiences using a supplemental feeding tube device: finding an alternative. J Hum Lact. 2005 Nov;21(4):429-38. — View Citation

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

Cheales-Siebenaler NJ. Induced lactation in an adoptive mother. J Hum Lact. 1999 Mar;15(1):41-3. — View Citation

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. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.