Supplemental Nursing System Compared to Bottle Supplementation
NCT ID: NCT04638075
Last Updated: 2022-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-01-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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).
Interventions
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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).
Eligibility Criteria
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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.
1 Day
50 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Christine Bonavita, BSN
Role: PRINCIPAL_INVESTIGATOR
Colorado University
References
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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
Other Identifiers
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20-0185
Identifier Type: -
Identifier Source: org_study_id
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