Donor Breast Milk and Breastfeeding Rates

NCT04572581 | Completed

• 1 other identifier: 19-002179
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.

Conditions

Breastfeeding, Exclusive; Breastfeeding

Keywords

Late Preterm; Donor Breast Milk

Outcome Measures

Primary Outcomes (3)

• Study Feasibility_1

  Feasibility will be evaluated by: consent rate

  6-8 weeks chronological age

• Study Feasibility_2

  Feasibility will be evaluated by: study completion rate

  6-8 weeks chronological age

• Study Feasibility_3

  Feasibility will be evaluated by: rate of adherence to the study diet.

  6-8 weeks chronological age

Secondary Outcomes (7)

• Percentage of Human Milk Consumption at Discharge

  at the time of NICU discharge or 7 days of age, whichever is later

• Percentage of Human Milk Consumption After Discharge

  6-8 weeks chronological age

• Breastfeeding duration

  6-8 weeks chronological age

• Intent to Breastfeed

  6-8 weeks chronological age

• Growth: Weight

  6-8 weeks chronological age

Other Outcomes (2)

• Intestinal Microbiome: microbial profiling (genus level)

  7 days of age

• Intestinal Microbiome: alpha diversity (Chao1)

  7 days of age

Study Arms (2)

Exclusively Human Milk Diet

EXPERIMENTAL

This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation.

Other: Donor Breast Milk

Formula-based Diet

NO INTERVENTION

If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care).

Interventions

Donor Breast Milk OTHER

Donor breast milk will be given to the newborn if supplementation is required

Exclusively Human Milk Diet

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \>34 weeks and 0 days
• Mother's intent to breast feed
• NICU admission which is predicted to be at least 72 hours from time of admission

You may not qualify if:

• Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies)
• Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc)
• Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana)
• Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications
• Any infant whose care is considered futile by the primary medical team

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90025, United States

Location

Santa Monica-UCLA

Los Angeles, California, 90404, United States

Location

Related Publications (29)

• Adamkin DH. Feeding problems in the late preterm infant. Clin Perinatol. 2006 Dec;33(4):831-7; abstract ix. doi: 10.1016/j.clp.2006.09.003.

  PMID: 17148007 BACKGROUND

• Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0.

  PMID: 19881390 BACKGROUND

• Backstrom MC, Aine L, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Maki M. Maturation of primary and permanent teeth in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F104-8. doi: 10.1136/fn.83.2.f104.

  PMID: 10952702 BACKGROUND

• Cleaveland K. Feeding challenges in the late preterm infant. Neonatal Netw. 2010 Jan-Feb;29(1):37-41. doi: 10.1891/0730-0832.29.1.37.

  PMID: 20085875 BACKGROUND

• Darcy AE. Complications of the late preterm infant. J Perinat Neonatal Nurs. 2009 Jan-Mar;23(1):78-86. doi: 10.1097/JPN.0b013e31819685b6.

  PMID: 19209064 BACKGROUND

• DeMauro SB, Patel PR, Medoff-Cooper B, Posencheg M, Abbasi S. Postdischarge feeding patterns in early- and late-preterm infants. Clin Pediatr (Phila). 2011 Oct;50(10):957-62. doi: 10.1177/0009922811409028. Epub 2011 Aug 19.

  PMID: 21856965 BACKGROUND

• Engle WA, Tomashek KM, Wallman C; Committee on Fetus and Newborn, American Academy of Pediatrics. "Late-preterm" infants: a population at risk. Pediatrics. 2007 Dec;120(6):1390-401. doi: 10.1542/peds.2007-2952.

  PMID: 18055691 BACKGROUND

• Fein SB, Labiner-Wolfe J, Shealy KR, Li R, Chen J, Grummer-Strawn LM. Infant Feeding Practices Study II: study methods. Pediatrics. 2008 Oct;122 Suppl 2:S28-35. doi: 10.1542/peds.2008-1315c.

  PMID: 18829828 BACKGROUND

• Gauer RL, Burket J, Horowitz E. Common questions about outpatient care of premature infants. Am Fam Physician. 2014 Aug 15;90(4):244-51.

  PMID: 25250998 BACKGROUND

• Gianni ML, Bezze EN, Sannino P, Baro M, Roggero P, Muscolo S, Plevani L, Mosca F. Maternal views on facilitators of and barriers to breastfeeding preterm infants. BMC Pediatr. 2018 Aug 27;18(1):283. doi: 10.1186/s12887-018-1260-2.

  PMID: 30149811 BACKGROUND

• Jain BK. Vitamin requirements of very low birth weight infants: a review. Indian J Matern Child Health. 1994 Apr-Jun;5(2):46-9.

  PMID: 12318806 BACKGROUND

• Kalyoncu O, Aygun C, Cetinoglu E, Kucukoduk S. Neonatal morbidity and mortality of late-preterm babies. J Matern Fetal Neonatal Med. 2010 Jul;23(7):607-12. doi: 10.1080/14767050903229622.

  PMID: 19757335 BACKGROUND

• Lapillonne A, O'Connor DL, Wang D, Rigo J. Nutritional recommendations for the late-preterm infant and the preterm infant after hospital discharge. J Pediatr. 2013 Mar;162(3 Suppl):S90-100. doi: 10.1016/j.jpeds.2012.11.058.

  PMID: 23445854 BACKGROUND

• Lucas A, Morley R, Cole TJ, Gore SM. A randomised multicentre study of human milk versus formula and later development in preterm infants. Arch Dis Child Fetal Neonatal Ed. 1994 Mar;70(2):F141-6. doi: 10.1136/fn.70.2.f141.

  PMID: 8154907 BACKGROUND

• Lucas A, Morley R, Cole TJ. Randomised trial of early diet in preterm babies and later intelligence quotient. BMJ. 1998 Nov 28;317(7171):1481-7. doi: 10.1136/bmj.317.7171.1481.

  PMID: 9831573 BACKGROUND

• Meier P, Patel AL, Wright K, Engstrom JL. Management of breastfeeding during and after the maternity hospitalization for late preterm infants. Clin Perinatol. 2013 Dec;40(4):689-705. doi: 10.1016/j.clp.2013.07.014. Epub 2013 Sep 21.

  PMID: 24182956 BACKGROUND

• Raju TN, Higgins RD, Stark AR, Leveno KJ. Optimizing care and outcome for late-preterm (near-term) infants: a summary of the workshop sponsored by the National Institute of Child Health and Human Development. Pediatrics. 2006 Sep;118(3):1207-14. doi: 10.1542/peds.2006-0018.

  PMID: 16951017 BACKGROUND

• Raju TN. Late-preterm births: challenges and opportunities. Pediatrics. 2008 Feb;121(2):402-3. doi: 10.1542/peds.2007-2357. No abstract available.

  PMID: 18245431 BACKGROUND

• Schanler RJ, Shulman RJ, Lau C. Feeding strategies for premature infants: beneficial outcomes of feeding fortified human milk versus preterm formula. Pediatrics. 1999 Jun;103(6 Pt 1):1150-7. doi: 10.1542/peds.103.6.1150.

  PMID: 10353922 BACKGROUND

• Schanler RJ, Lau C, Hurst NM, Smith EO. Randomized trial of donor human milk versus preterm formula as substitutes for mothers' own milk in the feeding of extremely premature infants. Pediatrics. 2005 Aug;116(2):400-6. doi: 10.1542/peds.2004-1974.

  PMID: 16061595 BACKGROUND

• Tomashek KM, Shapiro-Mendoza CK, Weiss J, Kotelchuck M, Barfield W, Evans S, Naninni A, Declercq E. Early discharge among late preterm and term newborns and risk of neonatal morbidity. Semin Perinatol. 2006 Apr;30(2):61-8. doi: 10.1053/j.semperi.2006.02.003.

  PMID: 16731278 BACKGROUND

• Torrazza RM, Neu J. The altered gut microbiome and necrotizing enterocolitis. Clin Perinatol. 2013 Mar;40(1):93-108. doi: 10.1016/j.clp.2012.12.009.

  PMID: 23415266 BACKGROUND

• Giapros VI, Schiza V, Challa AS, Cholevas VK, Theocharis PD, Kolios G, Pantou C, Andronikou SK. Vitamin D and parathormone levels of late-preterm formula fed infants during the first year of life. Eur J Clin Nutr. 2012 Feb;66(2):224-30. doi: 10.1038/ejcn.2011.158. Epub 2011 Sep 7.

  PMID: 21897423 BACKGROUND

• Ip S, Chung M, Raman G, Trikalinos TA, Lau J. A summary of the Agency for Healthcare Research and Quality's evidence report on breastfeeding in developed countries. Breastfeed Med. 2009 Oct;4 Suppl 1:S17-30. doi: 10.1089/bfm.2009.0050.

  PMID: 19827919 BACKGROUND

• Valentine G, Chu DM, Stewart CJ, Aagaard KM. Relationships Between Perinatal Interventions, Maternal-Infant Microbiomes, and Neonatal Outcomes. Clin Perinatol. 2018 Jun;45(2):339-355. doi: 10.1016/j.clp.2018.01.008. Epub 2018 Feb 23.

  PMID: 29747892 BACKGROUND

• Walker M. Breastfeeding the late preterm infant. J Obstet Gynecol Neonatal Nurs. 2008 Nov-Dec;37(6):692-701. doi: 10.1111/j.1552-6909.2008.00293.x.

  PMID: 19012718 BACKGROUND

• Young L, Morgan J, McCormick FM, McGuire W. Nutrient-enriched formula versus standard term formula for preterm infants following hospital discharge. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD004696. doi: 10.1002/14651858.CD004696.pub4.

  PMID: 22419297 BACKGROUND

• Caporaso JG, Lauber CL, Walters WA, Berg-Lyons D, Huntley J, Fierer N, Owens SM, Betley J, Fraser L, Bauer M, Gormley N, Gilbert JA, Smith G, Knight R. Ultra-high-throughput microbial community analysis on the Illumina HiSeq and MiSeq platforms. ISME J. 2012 Aug;6(8):1621-4. doi: 10.1038/ismej.2012.8. Epub 2012 Mar 8.

  PMID: 22402401 BACKGROUND

• Callahan BJ, McMurdie PJ, Rosen MJ, Han AW, Johnson AJ, Holmes SP. DADA2: High-resolution sample inference from Illumina amplicon data. Nat Methods. 2016 Jul;13(7):581-3. doi: 10.1038/nmeth.3869. Epub 2016 May 23.

  PMID: 27214047 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Kara L Calkins, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Clinical Assistant Professor, Pediatric Neonatology

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 1, 2020
• Study Start: November 1, 2020
• Primary Completion: June 26, 2022
• Study Completion: August 15, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)