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This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very preterm infants receiving breast milk |
| ||
| Very preterm infants receiving donor breast milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maternal breast milk | Other | Very preterm infants receiving maternal breast milk |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Average Serum ferritin level in very preterm infants | The average serum ferritin level (ng/ml) in very preterm infants receiving donor breast milk or maternal breast milk | Until four weeks of age or discharge |
| Measure | Description | Time Frame |
|---|---|---|
| The Average Hemoglobin levels (g/dl) in very preterm infants | The average Hemoglobin levels (g/dL) in very preterm infants receiving donor breast milk or maternal breast milk | Until four weeks of age or discharge |
| The Average Bilirubin Levels (mg/dL) in very preterm infants |
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Inclusion Criteria:
All preterm infants born between 29 weeks and 0 days -32 weeks and 6 days of gestational age and admitted to the NICU at Advent Health for Children
Received either MBM or DBM starting between 5 to10 days of life
a. Infants receiving >50% feeding volume by DBM for the first 14 days of life will be considered to have received predominantly DBM. The comparison group will be infants who received > 50% of MBM for the first 14 days of life.
Parent able to read and write in the English language.
Exclusion Criteria:
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Very preterm infants
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| Name | Affiliation | Role |
|---|---|---|
| Anoop Pulickal, MD | AdvenHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth | Orlando | Florida | 32803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31186148 | Background | Gao C, Miller J, Middleton PF, Huang YC, McPhee AJ, Gibson RA. Changes to breast milk fatty acid composition during storage, handling and processing: A systematic review. Prostaglandins Leukot Essent Fatty Acids. 2019 Jul;146:1-10. doi: 10.1016/j.plefa.2019.04.008. Epub 2019 May 1. | |
| 6848709 | Background | Maisels MJ, Gifford K. Breast-feeding, weight loss, and jaundice. J Pediatr. 1983 Jan;102(1):117-8. doi: 10.1016/s0022-3476(83)80305-9. No abstract available. |
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| Donor breast milk | Other | Very preterm infants receiving donor breast milk |
|
The average Hemoglobin levels (g/dL) in very preterm infants receiving donor breast milk or maternal breast milk |
| until four weeks of age or discharge |
| 24302687 | Background | Joy R, Krishnamurthy S, Bethou A, Rajappa M, Ananthanarayanan PH, Bhat BV. Early versus late enteral prophylactic iron supplementation in preterm very low birth weight infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F105-9. doi: 10.1136/archdischild-2013-304650. Epub 2013 Dec 3. |
| 28114607 | Background | Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971. |
| 30473033 | Background | Mercer JS, Erickson-Owens DA, Deoni SCL, Dean DC 3rd, Collins J, Parker AB, Wang M, Joelson S, Mercer EN, Padbury JF. Effects of Delayed Cord Clamping on 4-Month Ferritin Levels, Brain Myelin Content, and Neurodevelopment: A Randomized Controlled Trial. J Pediatr. 2018 Dec;203:266-272.e2. doi: 10.1016/j.jpeds.2018.06.006. Epub 2018 Jul 6. |
| 34324880 | Background | German KR, Vu PT, Comstock BA, Ohls RK, Heagerty PJ, Mayock DE, Georgieff M, Rao R, Juul SE; PENUT Consortium. Enteral Iron Supplementation in Infants Born Extremely Preterm and its Positive Correlation with Neurodevelopment; Post Hoc Analysis of the Preterm Erythropoietin Neuroprotection Trial Randomized Controlled Trial. J Pediatr. 2021 Nov;238:102-109.e8. doi: 10.1016/j.jpeds.2021.07.019. Epub 2021 Jul 27. |
| 27540206 | Background | Taufek NM, Cartwright D, Hewavitharana A, Koorts P, McConachy H, Shaw N, Whitfield K, Davies M. TO INVESTIGATE THE EFFECT OF THE PASTEURISATION PROCESS ON TRACE ELEMENTS IN DONOR BREAST MILK. Arch Dis Child. 2016 Sep;101(9):e2. doi: 10.1136/archdischild-2016-311535.27. |
| 27253894 | Background | Mohd-Taufek N, Cartwright D, Davies M, Hewavitharana AK, Koorts P, McConachy H, Shaw PN, Sumner R, Whitfield K. The effect of pasteurization on trace elements in donor breast milk. J Perinatol. 2016 Oct;36(10):897-900. doi: 10.1038/jp.2016.88. Epub 2016 Jun 2. |
| 29287170 | Background | Mannel R, Peck JD. Outcomes Associated With Type of Milk Supplementation Among Late Preterm Infants. J Obstet Gynecol Neonatal Nurs. 2018 Jul;47(4):571-582. doi: 10.1016/j.jogn.2017.11.005. Epub 2017 Dec 27. |
| 25117506 | Background | Stoltz Sjostrom E, Ohlund I, Tornevi A, Domellof M. Intake and macronutrient content of human milk given to extremely preterm infants. J Hum Lact. 2014 Nov;30(4):442-9. doi: 10.1177/0890334414546354. Epub 2014 Aug 12. |
| 30565323 | Background | Hard AL, Nilsson AK, Lund AM, Hansen-Pupp I, Smith LEH, Hellstrom A. Review shows that donor milk does not promote the growth and development of preterm infants as well as maternal milk. Acta Paediatr. 2019 Jun;108(6):998-1007. doi: 10.1111/apa.14702. Epub 2019 Jan 25. |
| 31322731 | Background | Quigley M, Embleton ND, McGuire W. Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database Syst Rev. 2019 Jul 19;7(7):CD002971. doi: 10.1002/14651858.CD002971.pub5. |
| 20443660 | Background | Arslanoglu S, Ziegler EE, Moro GE; World Association of Perinatal Medicine Working Group On Nutrition. Donor human milk in preterm infant feeding: evidence and recommendations. J Perinat Med. 2010 Jul;38(4):347-51. doi: 10.1515/jpm.2010.064. |
| Background | American Academy of Pediatrics Policy Statement. Breastfeeding and the use of breast milk. Pediatrics 2012; 129:e827-841 |