Growth Failure Clinical Trial
Official title:
Targeted Fortification of Donor Breast Milk in Preterm Infants
NCT number | NCT04294368 |
Other study ID # | AAAS6625 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2020 |
Est. completion date | April 2025 |
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 21 Days |
Eligibility | Inclusion Criteria: - Premature infants born </= 30 weeks gestational age - Birth Weight </= 1500 grams Exclusion Criteria: - Parents do no consent to donor milk - Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies - Grade III or IV intraventricular hemorrhage diagnoses prior to randomization - Small for gestational age (<3% on Fenton Growth Curve) - Failure to initiate fortified feeds prior to 3 weeks of life - Diagnosis of necrotizing entercolitis prior to randomization - Diagnosis of early onset sepsis confirmed with positive culture |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center/ New York - Presbyterian | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Arslanoglu S, Boquien CY, King C, Lamireau D, Tonetto P, Barnett D, Bertino E, Gaya A, Gebauer C, Grovslien A, Moro GE, Weaver G, Wesolowska AM, Picaud JC. Fortification of Human Milk for Preterm Infants: Update and Recommendations of the European Milk Bank Association (EMBA) Working Group on Human Milk Fortification. Front Pediatr. 2019 Mar 22;7:76. doi: 10.3389/fped.2019.00076. eCollection 2019. — View Citation
Billard H, Simon L, Desnots E, Sochard A, Boscher C, Riaublanc A, Alexandre-Gouabau MC, Boquien CY. Calibration Adjustment of the Mid-infrared Analyzer for an Accurate Determination of the Macronutrient Composition of Human Milk. J Hum Lact. 2016 Aug;32(3):NP19-27. doi: 10.1177/0890334415588513. Epub 2015 Jun 2. — View Citation
Fusch C. Avoiding Postnatal Growth Retardation by Individualized Fortification of Breast Milk: Implications for Somatic and Neurodevelopmental Outcomes. Breastfeed Med. 2019 Apr;14(S1):S15-S17. doi: 10.1089/bfm.2019.0031. No abstract available. — View Citation
Fusch G, Rochow N, Choi A, Fusch S, Poeschl S, Ubah AO, Lee SY, Raja P, Fusch C. Rapid measurement of macronutrients in breast milk: How reliable are infrared milk analyzers? Clin Nutr. 2015 Jun;34(3):465-76. doi: 10.1016/j.clnu.2014.05.005. Epub 2014 May 17. — View Citation
Gidrewicz DA, Fenton TR. A systematic review and meta-analysis of the nutrient content of preterm and term breast milk. BMC Pediatr. 2014 Aug 30;14:216. doi: 10.1186/1471-2431-14-216. — View Citation
Horbar JD, Ehrenkranz RA, Badger GJ, Edwards EM, Morrow KA, Soll RF, Buzas JS, Bertino E, Gagliardi L, Bellu R. Weight Growth Velocity and Postnatal Growth Failure in Infants 501 to 1500 Grams: 2000-2013. Pediatrics. 2015 Jul;136(1):e84-92. doi: 10.1542/peds.2015-0129. — View Citation
John A, Sun R, Maillart L, Schaefer A, Hamilton Spence E, Perrin MT. Macronutrient variability in human milk from donors to a milk bank: Implications for feeding preterm infants. PLoS One. 2019 Jan 25;14(1):e0210610. doi: 10.1371/journal.pone.0210610. eCollection 2019. — View Citation
Montjaux-Regis N, Cristini C, Arnaud C, Glorieux I, Vanpee M, Casper C. Improved growth of preterm infants receiving mother's own raw milk compared with pasteurized donor milk. Acta Paediatr. 2011 Dec;100(12):1548-54. doi: 10.1111/j.1651-2227.2011.02389.x. Epub 2011 Jul 14. — View Citation
Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y. — View Citation
O'Connor DL, Ewaschuk JB, Unger S. Human milk pasteurization: benefits and risks. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):269-75. doi: 10.1097/MCO.0000000000000160. — View Citation
Quan M, Wang D, Gou L, Sun Z, Ma J, Zhang L, Wang C, Schibler K, Li Z. Individualized Human Milk Fortification to Improve the Growth of Hospitalized Preterm Infants. Nutr Clin Pract. 2020 Aug;35(4):680-688. doi: 10.1002/ncp.10366. Epub 2019 Jul 3. — View Citation
Rochow N, Fusch G, Choi A, Chessell L, Elliott L, McDonald K, Kuiper E, Purcha M, Turner S, Chan E, Xia MY, Fusch C. Target fortification of breast milk with fat, protein, and carbohydrates for preterm infants. J Pediatr. 2013 Oct;163(4):1001-7. doi: 10.1016/j.jpeds.2013.04.052. Epub 2013 Jun 12. — View Citation
Zhu M, Yang Z, Ren Y, Duan Y, Gao H, Liu B, Ye W, Wang J, Yin S. Comparison of macronutrient contents in human milk measured using mid-infrared human milk analyser in a field study vs. chemical reference methods. Matern Child Nutr. 2017 Jan;13(1):10.1111/mcn.12248. doi: 10.1111/mcn.12248. Epub 2016 Feb 23. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in weight | Weight change in g/kg/day, z-score value, and change in z-score from week-to-week | Up to 11 weeks | |
Primary | Change in length | Length change in cm/kg/day, z-score value, and change in z-score from week-to-week | Up to 11 weeks | |
Primary | Head circumference | Head circumference change in cm/kg/day, z-score value, and change in z-score from week-to-week | Up to 11 weeks | |
Secondary | Total Number of Days of Length of Stay in NICU | Today number of days in the NICU. | Up to 1 year | |
Secondary | Rate of Mortality | Rate of morality during NICU hospitalization. | Up to one year | |
Secondary | Number of Feeding Intolerance Events | The number of feeding intolerance events, defined as 1 or more feeds held. | Up to 34 weeks corrected gestational age | |
Secondary | Number of Necrotizing Enterocolitis Events | Number of necrotizing enterocolotis events. | Up to 1 year of age | |
Secondary | Incidence of Bronchopulmonary dysplasia | Incidence of supplemental oxygen requirement at 36 weeks corrected gestational age. | Up to 1 year of age | |
Secondary | Incidence of Retinopathy of prematurity | Incidence of retinopathy of prematurity | Up to 1 year of age | |
Secondary | Percentage of Feeds with Donor Milk and Mother's Milk | Percent of feeds that are donor milk and mom's own milk. | Up to 34 weeks corrected gestational age |
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