<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03839173</url>
  </required_header>
  <id_info>
    <org_study_id>1147989-3</org_study_id>
    <nct_id>NCT03839173</nct_id>
  </id_info>
  <brief_title>Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet</brief_title>
  <acronym>MedolacHMF</acronym>
  <official_title>Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Augusta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Neolac Inc dba Medolac Laboratories</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Augusta University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this two-arm investigation is to determine if growth patterns of very low&#xD;
      birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor)&#xD;
      supplemented with a human milk-based fortifier grow according to established guidelines and&#xD;
      maintain adequate micronutrient levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To achieve this goal, the investigators will prospectively analyze the growth and&#xD;
      micronutrient status of VLBW infants who are fed human milk (maternal or donor) supplemented&#xD;
      with a human-milk-based fortifier with increased protein (Medolac® Human Milk Fortifier). In&#xD;
      addition, the investigators will compare the findings to retrospectively collected data for&#xD;
      growth rates and micronutrient status of infants who received human milk fortified with cow's&#xD;
      milk -based fortifier (Enfamil® Hydrolyzed Liquid Human Milk Fortifier). The investigators&#xD;
      hypothesize that a human milk-based fortifier with increased protein will support growth at&#xD;
      recommended levels (weight gain of 12-18 g/kg/day, head circumference 0.75-1.0 cm/week,&#xD;
      length 0.8-1.1 cm/week)[1-3] and prevent micronutrient deficiency in the VLBW infant&#xD;
&#xD;
      Aim 1: To determine if VLBW infants fed human milk, maternal or donor, supplemented with a&#xD;
      human milk-based fortifier with increased protein grow at recommended levels for weight,&#xD;
      length, and head circumference. To achieve this aim, Z-scores for weight, length, and head&#xD;
      circumference will be tracked. Measurements will be taken at birth and then weekly until 36&#xD;
      weeks post-menstrual age (PMA) or discharge from the neonatal intensive care unit (NICU),&#xD;
      whichever comes first. Aim 2: To measure nutritional status in VLBW premature infants fed&#xD;
      human milk supplemented with a human milk-based fortifier with increased protein. To achieve&#xD;
      this aim, serum magnesium, potassium, chloride, blood urea nitrogen (BUN), creatinine,&#xD;
      sodium, calcium, phosphorus, CO2, Vitamin D 1, 25 (OH) 2D, parathyroid hormone (PTH),&#xD;
      alkaline phosphatase, hemoglobin, hematocrit will be measured within 24 hours of reaching&#xD;
      full enteral feedings and repeated seven days later, and then every fourteen days until 36&#xD;
      weeks PMA or discharge, whichever comes first. Urine magnesium and sodium will be measured on&#xD;
      the same schedule.&#xD;
&#xD;
      Aim 3: To compare growth rates and nutritional status of VLBW infants fed human milk&#xD;
      fortified with a human milk-based fortifier to growth rates and nutritional status of those&#xD;
      fed human milk fortified with a cow's milk-based fortifier.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">July 25, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Return to birth weight day</measure>
    <time_frame>birth to 30 days</time_frame>
    <description>Day of life infant returns to birth weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Growth Velocity</measure>
    <time_frame>Weekly until 36 weeks post menstrual age or discharge</time_frame>
    <description>rate of weight gain measured as g/kg/day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Serum Magnesium</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>Serum and urine Magnesium</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Serum CO2</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>Serum CO2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean z-scores</measure>
    <time_frame>Weekly until 36 weeks post menstrual age or discharge</time_frame>
    <description>z-scores for weight, length, and head circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean serum Vitamin D, 1 25 (OH) 2D</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>serum Vitamin D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean serum parathyroid Hormone (PTH)</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>Serum PTH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean serum Sodium</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>Serum and urine Sodium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean serum Blood Urea Nitrogen (BUN)</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>serum BUN</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean serum Calcium</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>serum Calcium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean serum Phosphorus</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>serum Phosphorus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean serum Alkaline Phosphatase</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>serum Alkaline Phosphatase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean serum Hemoglobin</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>serum Hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean serum Potassium</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>serum and urine Potassium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean serum Hematocrit</measure>
    <time_frame>Every 14 days until 36 weeks post menstrual age or discharge</time_frame>
    <description>serum Hematocrit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">51</enrollment>
  <condition>Premature Infant</condition>
  <condition>Breast Milk Expression</condition>
  <arm_group>
    <arm_group_label>Retrospective Chart Review</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Retrospective Chart Review for historical controls. Historic controls fed cow's milk fortifier</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prospective</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All neonates with birth weights ranging from 750-1500 grams and gestational ages 23-33 weeks admitted to the NICU at Augusta University within 24 hours of life will be eligible for screening within 72 hours of admission and upon parent's or legal guardian's consent.&#xD;
Infants will be fed a human milk fortifier made with donor human milk. Data will be compared with historic control data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Human milk based human milk fortifier</intervention_name>
    <description>A human milk fortifier with added minerals made from donor human milk</description>
    <arm_group_label>Prospective</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Birth weight 750-1800 grams&#xD;
&#xD;
          2. Admitted to AU NICU within 24 hours of life&#xD;
&#xD;
          3. Estimated gestational age (EGA) 23 to 33 weeks as confirmed by the Ballard score&#xD;
&#xD;
          4. Birth weight appropriate for gestational age (AGA) defined as &gt;3rd% on a&#xD;
             gender-specific Fenton growth curve (Fenton 2013, Calgary, Canada)&#xD;
&#xD;
          5. Enteral feedings initiated within 7 days of life&#xD;
&#xD;
          6. Breastmilk diet, maternal or donor milk&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Renal conditions affecting electrolyte metabolism and/or excretion&#xD;
&#xD;
          2. Gastro-intestinal conditions that preclude feeding or affect nutrient absorption&#xD;
             (gastroschisis, omphalocele)&#xD;
&#xD;
          3. EGA &gt;33 weeks or birth weight &gt;1800 grams or EGA &lt;23 weeks or birth weight &lt;750 grams&#xD;
&#xD;
          4. Apgar &lt;3 at 5 minutes&#xD;
&#xD;
          5. Grade 3 or higher intraventricular hemorrhage (IVH)&#xD;
&#xD;
          6. Intrauterine growth restriction (IUGR), as defined as &lt;3rd% on a gender-specific&#xD;
             Fenton growth curve&#xD;
&#xD;
          7. Congenital anomalies including congenital heart disease or other major defect&#xD;
             requiring surgical intervention&#xD;
&#xD;
          8. Intake of cow's milk formula or fortifier before or after the initiation of the study&#xD;
             protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Weeks</minimum_age>
    <maximum_age>33 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Gates, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Augusta University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1253-61. doi: 10.1542/peds.2005-1368.</citation>
    <PMID>16585322</PMID>
  </reference>
  <reference>
    <citation>Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.</citation>
    <PMID>23601190</PMID>
  </reference>
  <reference>
    <citation>Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.</citation>
    <PMID>22371471</PMID>
  </reference>
  <reference>
    <citation>Koletsko B PB, Uauy R. Nutritional Care of Preterm Infants. Basel, Switzerland: Karger, 2014.</citation>
  </reference>
  <reference>
    <citation>Kim JH, Chan G, Schanler R, Groh-Wargo S, Bloom B, Dimmit R, Williams L, Baggs G, Barrett-Reis B. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. J Pediatr Gastroenterol Nutr. 2015 Dec;61(6):665-71. doi: 10.1097/MPG.0000000000001010. Erratum In: J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):188-9.</citation>
    <PMID>26488118</PMID>
  </reference>
  <reference>
    <citation>Moya F, Sisk PM, Walsh KR, Berseth CL. A new liquid human milk fortifier and linear growth in preterm infants. Pediatrics. 2012 Oct;130(4):e928-35. doi: 10.1542/peds.2011-3120. Epub 2012 Sep 17.</citation>
    <PMID>22987877</PMID>
  </reference>
  <reference>
    <citation>Sullivan S, Schanler RJ, Kim JH, Patel AL, Trawoger R, Kiechl-Kohlendorfer U, Chan GM, Blanco CL, Abrams S, Cotten CM, Laroia N, Ehrenkranz RA, Dudell G, Cristofalo EA, Meier P, Lee ML, Rechtman DJ, Lucas A. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010 Apr;156(4):562-7.e1. doi: 10.1016/j.jpeds.2009.10.040. Epub 2009 Dec 29.</citation>
    <PMID>20036378</PMID>
  </reference>
  <reference>
    <citation>Gates A BJ. [Neonatal Outcomes Augusta Univeristy NICU] Unpublished raw data. Augusta 2017.</citation>
  </reference>
  <reference>
    <citation>Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.</citation>
    <PMID>20732945</PMID>
  </reference>
  <reference>
    <citation>Thoene M, Hanson C, Lyden E, Dugick L, Ruybal L, Anderson-Berry A. Comparison of the effect of two human milk fortifiers on clinical outcomes in premature infants. Nutrients. 2014 Jan 3;6(1):261-75. doi: 10.3390/nu6010261.</citation>
    <PMID>24394538</PMID>
  </reference>
  <reference>
    <citation>Kumar N, Monga R, Sampath V, Ehrhart B. Prospective Comparison of Enfamil and Similac Liquid Human Milk Fortifier on Clinical Outcomes in Premature Infants. Am J Perinatol. 2017 Dec;34(14):1411-1416. doi: 10.1055/s-0037-1603940. Epub 2017 Jun 21. No abstract available.</citation>
    <PMID>28637062</PMID>
  </reference>
  <reference>
    <citation>Cristofalo EA, Schanler RJ, Blanco CL, Sullivan S, Trawoeger R, Kiechl-Kohlendorfer U, Dudell G, Rechtman DJ, Lee ML, Lucas A, Abrams S. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013 Dec;163(6):1592-1595.e1. doi: 10.1016/j.jpeds.2013.07.011. Epub 2013 Aug 20.</citation>
    <PMID>23968744</PMID>
  </reference>
  <reference>
    <citation>Gross SJ. Growth and biochemical response of preterm infants fed human milk or modified infant formula. N Engl J Med. 1983 Feb 3;308(5):237-41. doi: 10.1056/NEJM198302033080501.</citation>
    <PMID>6848932</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19881390</PMID>
  </reference>
  <reference>
    <citation>Ong KK, Kennedy K, Castaneda-Gutierrez E, Forsyth S, Godfrey KM, Koletzko B, Latulippe ME, Ozanne SE, Rueda R, Schoemaker MH, van der Beek EM, van Buuren S, Fewtrell M. Postnatal growth in preterm infants and later health outcomes: a systematic review. Acta Paediatr. 2015 Oct;104(10):974-86. doi: 10.1111/apa.13128.</citation>
    <PMID>26179961</PMID>
  </reference>
  <reference>
    <citation>Ghandehari H, Lee ML, Rechtman DJ; H2MF Study Group. An exclusive human milk-based diet in extremely premature infants reduces the probability of remaining on total parenteral nutrition: a reanalysis of the data. BMC Res Notes. 2012 Apr 25;5:188. doi: 10.1186/1756-0500-5-188.</citation>
    <PMID>22534258</PMID>
  </reference>
  <reference>
    <citation>Food and Drug Administration, HHS. Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule. Fed Regist. 2014 Jun 10;79(111):33057-72.</citation>
    <PMID>24922980</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 25, 2019</last_update_submitted>
  <last_update_submitted_qc>July 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Augusta University</investigator_affiliation>
    <investigator_full_name>Amy Gates</investigator_full_name>
    <investigator_title>Registered Dietitian and Pediatric Nutrition Specialist</investigator_title>
  </responsible_party>
  <keyword>premature infant</keyword>
  <keyword>breast milk</keyword>
  <keyword>breastmilk</keyword>
  <keyword>human milk</keyword>
  <keyword>human milk fortifier</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Birth Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03839173
org study id: 1147989-3
nct id: NCT03839173
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this two-arm investigation is to determine if growth patterns of very low
      birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor)
      supplemented with a human milk-based fortifier grow according to established guidelines and
      maintain adequate micronutrient levels.
To achieve this goal, the investigators will prospectively analyze the growth and
      micronutrient status of VLBW infants who are fed human milk (maternal or donor) supplemented
      with a human-milk-based fortifier with increased protein (Medolac® Human Milk Fortifier). In
      addition, the investigators will compare the findings to retrospectively collected data for
      growth rates and micronutrient status of infants who received human milk fortified with cow's
      milk -based fortifier (Enfamil® Hydrolyzed Liquid Human Milk Fortifier). The investigators
      hypothesize that a human milk-based fortifier with increased protein will support growth at
      recommended levels (weight gain of 12-18 g/kg/day, head circumference 0.75-1.0 cm/week,
      length 0.8-1.1 cm/week)[1-3] and prevent micronutrient deficiency in the VLBW infant

      Aim 1: To determine if VLBW infants fed human milk, maternal or donor, supplemented with a
      human milk-based fortifier with increased protein grow at recommended levels for weight,
      length, and head circumference. To achieve this aim, Z-scores for weight, length, and head
      circumference will be tracked. Measurements will be taken at birth and then weekly until 36
      weeks post-menstrual age (PMA) or discharge from the neonatal intensive care unit (NICU),
      whichever comes first. Aim 2: To measure nutritional status in VLBW premature infants fed
      human milk supplemented with a human milk-based fortifier with increased protein. To achieve
      this aim, serum magnesium, potassium, chloride, blood urea nitrogen (BUN), creatinine,
      sodium, calcium, phosphorus, CO2, Vitamin D 1, 25 (OH) 2D, parathyroid hormone (PTH),
      alkaline phosphatase, hemoglobin, hematocrit will be measured within 24 hours of reaching
      full enteral feedings and repeated seven days later, and then every fourteen days until 36
      weeks PMA or discharge, whichever comes first. Urine magnesium and sodium will be measured on
      the same schedule.

      Aim 3: To compare growth rates and nutritional status of VLBW infants fed human milk
      fortified with a human milk-based fortifier to growth rates and nutritional status of those
      fed human milk fortified with a cow's milk-based fortifier.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Return to birth weight day
time frame: birth to 30 days
description: Day of life infant returns to birth weight
measure: Growth Velocity
time frame: Weekly until 36 weeks post menstrual age or discharge
description: rate of weight gain measured as g/kg/day
measure: Mean Serum Magnesium
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: Serum and urine Magnesium
measure: Mean Serum CO2
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: Serum CO2
measure: Mean z-scores
time frame: Weekly until 36 weeks post menstrual age or discharge
description: z-scores for weight, length, and head circumference
measure: Mean serum Vitamin D, 1 25 (OH) 2D
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: serum Vitamin D
measure: Mean serum parathyroid Hormone (PTH)
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: Serum PTH
measure: Mean serum Sodium
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: Serum and urine Sodium
measure: Mean serum Blood Urea Nitrogen (BUN)
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: serum BUN
measure: Mean serum Calcium
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: serum Calcium
measure: Mean serum Phosphorus
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: serum Phosphorus
measure: Mean serum Alkaline Phosphatase
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: serum Alkaline Phosphatase
measure: Mean serum Hemoglobin
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: serum Hemoglobin
measure: Mean serum Potassium
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: serum and urine Potassium
measure: Mean serum Hematocrit
time frame: Every 14 days until 36 weeks post menstrual age or discharge
description: serum Hematocrit
arm group label: Retrospective Chart Review
arm group type: No Intervention
description: Retrospective Chart Review for historical controls. Historic controls fed cow's milk fortifier
arm group label: Prospective
arm group type: Experimental
description: All neonates with birth weights ranging from 750-1500 grams and gestational ages 23-33 weeks admitted to the NICU at Augusta University within 24 hours of life will be eligible for screening within 72 hours of admission and upon parent's or legal guardian's consent.
Infants will be fed a human milk fortifier made with donor human milk. Data will be compared with historic control data.
intervention type: Other
intervention name: Human milk based human milk fortifier
description: A human milk fortifier with added minerals made from donor human milk
arm group label: Prospective
criteria: 
gender: All
minimum age: 23 Weeks
maximum age: 33 Weeks
healthy volunteers: No
last name: Amy Gates, RD
role: Principal Investigator
affiliation: Augusta University
facility: 
country: United States
citation: Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1253-61. doi: 10.1542/peds.2005-1368.
PMID: 16585322
citation: Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.
PMID: 23601190
citation: Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
PMID: 22371471
citation: Koletsko B PB, Uauy R. Nutritional Care of Preterm Infants. Basel, Switzerland: Karger, 2014.
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responsible party type: Principal Investigator
investigator affiliation: Augusta University
investigator full name: Amy Gates
investigator title: Registered Dietitian and Pediatric Nutrition Specialist
mesh term: Birth Weight
sharing ipd: No