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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
32 participants
INTERVENTIONAL
2020-11-01
2022-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Human Milk Feeding Rates Post-NICU Discharge
NCT02692521
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
NCT01487928
Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
NCT01232725
Effect of Breast Milk Feeding on Critically Ill Neonates
NCT05816408
A Quality Improvement Initiative to Increase Breast Milk Use in a Chinese NICU: a Pilot Study
NCT02897388
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exclusively Human Milk Diet
This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation.
Donor Breast Milk
Donor breast milk will be given to the newborn if supplementation is required
Formula-based Diet
If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care).
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Donor Breast Milk
Donor breast milk will be given to the newborn if supplementation is required
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mother's intent to breast feed
* NICU admission which is predicted to be at least 72 hours from time of admission
Exclusion Criteria
* 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
3 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, Los Angeles
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kara L. Calkins, MD
Health Sciences Clinical Assistant Professor, Pediatric Neonatology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kara L Calkins, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Santa Monica-UCLA
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Darcy AE. Complications of the late preterm infant. J Perinat Neonatal Nurs. 2009 Jan-Mar;23(1):78-86. doi: 10.1097/JPN.0b013e31819685b6.
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.
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.
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.
Gauer RL, Burket J, Horowitz E. Common questions about outpatient care of premature infants. Am Fam Physician. 2014 Aug 15;90(4):244-51.
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.
Jain BK. Vitamin requirements of very low birth weight infants: a review. Indian J Matern Child Health. 1994 Apr-Jun;5(2):46-9.
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.
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.
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.
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.
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.
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.
Raju TN. Late-preterm births: challenges and opportunities. Pediatrics. 2008 Feb;121(2):402-3. doi: 10.1542/peds.2007-2357. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
19-002179
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.