Premature InfantMedolacHMFNCT03839173
Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
A study testing Human milk based human milk fortifier in people with Premature Infant and Breast Milk Expression, run by Augusta University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 23 to 33 weeks
- Conditions the study is for
- Premature Infant, Breast Milk Expression
- What is being tested?
- Human milk based human milk fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight 750-1800 grams
- Admitted to AU NICU within 24 hours of life
- Estimated gestational age (EGA) 23 to 33 weeks as confirmed by the Ballard score
- Birth weight appropriate for gestational age (AGA) defined as >3rd% on a gender-specific Fenton growth curve (Fenton 2013, Calgary, Canada)
- Enteral feedings initiated within 7 days of life
- Breastmilk diet, maternal or donor milk
Who cannot join
- Renal conditions affecting electrolyte metabolism and/or excretion
- Gastro-intestinal conditions that preclude feeding or affect nutrient absorption (gastroschisis, omphalocele)
- EGA >33 weeks or birth weight >1800 grams or EGA <23 weeks or birth weight <750 grams
- Apgar <3 at 5 minutes
- Grade 3 or higher intraventricular hemorrhage (IVH)
- Intrauterine growth restriction (IUGR), as defined as <3rd% on a gender-specific Fenton growth curve
- Congenital anomalies including congenital heart disease or other major defect requiring surgical intervention
- Intake of cow's milk formula or fortifier before or after the initiation of the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Premature Infant, Breast Milk Expression
- Being tested
- Human milk based human milk fortifier
- Keywords
- premature infant, breast milk, breastmilk, human milk, human milk fortifier
- Medical subject headings
- Premature Birth, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milk based human milk fortifierOther
A human milk fortifier with added minerals made from donor human milk
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Chart Review | No intervention | Retrospective Chart Review for historical controls. Historic controls fed cow's milk fortifier |
| Prospective | Experimental | 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. Receives: Other: Human milk based human milk fortifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to birth weight day
Day of life infant returns to birth weight
Measured: birth to 30 days
Growth Velocity
rate of weight gain measured as g/kg/day
Measured: Weekly until 36 weeks post menstrual age or discharge
Mean Serum Magnesium
Serum and urine Magnesium
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Mean Serum CO2
Serum CO2
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Secondary outcomes (11)
Mean z-scores
z-scores for weight, length, and head circumference
Measured: Weekly until 36 weeks post menstrual age or discharge
Mean serum Vitamin D, 1 25 (OH) 2D
serum Vitamin D
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum parathyroid Hormone (PTH)
Serum PTH
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Sodium
Serum and urine Sodium
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Blood Urea Nitrogen (BUN)
serum BUN
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Calcium
serum Calcium
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Phosphorus
serum Phosphorus
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Alkaline Phosphatase
serum Alkaline Phosphatase
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Hemoglobin
serum Hemoglobin
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Potassium
serum and urine Potassium
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Hematocrit
serum Hematocrit
Measured: Every 14 days until 36 weeks post menstrual age or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start25 Jul 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Neolac Inc dba Medolac Laboratories
- Responsible party
- Principal investigator, Amy Gates, Augusta University
- Investigators
- Amy Gates, RD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839173
- Sponsor's protocol ID
- 1147989-3
- Acronym
- MedolacHMF
- Status last verified
- Jul 2019
- First submitted
- 11 Feb 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16585322Fenton 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.
PubMed 23601190Section 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.
PubMed 22371471Koletsko B PB, Uauy R. Nutritional Care of Preterm Infants. Basel, Switzerland: Karger, 2014.
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.
PubMed 26488118Moya 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.
PubMed 22987877Sullivan 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.
PubMed 20036378Gates A BJ. [Neonatal Outcomes Augusta Univeristy NICU] Unpublished raw data. Augusta 2017.
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.
PubMed 20732945Thoene 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.
PubMed 24394538Kumar 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.
PubMed 28637062Cristofalo 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.
PubMed 23968744Gross 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.
PubMed 6848932Agostoni 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.
PubMed 19881390Ong 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.
PubMed 26179961
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
- ClinicalTrials.gov ID
- NCT03839173
- Acronym / sponsor ID
- MedolacHMF / 1147989-3
- Conditions
- Premature Infant, Breast Milk Expression
- Keywords
- premature infant, breast milk, breastmilk, human milk, human milk fortifier
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Neolac Inc dba Medolac Laboratories
- Study start
- 25 Jul 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Chart Review | No intervention | –Retrospective Chart Review for historical controls. Historic controls fed cow's milk fortifier |
| Prospective | Experimental | Other: Human milk based human milk fortifierAll 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. |
Who may qualify
- Ages
- 23 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Birth weight 750-1800 grams
- Admitted to AU NICU within 24 hours of life
- Estimated gestational age (EGA) 23 to 33 weeks as confirmed by the Ballard score
- Birth weight appropriate for gestational age (AGA) defined as >3rd% on a gender-specific Fenton growth curve (Fenton 2013, Calgary, Canada)
- Enteral feedings initiated within 7 days of life
Key exclusion criteria (8 listed)
- Renal conditions affecting electrolyte metabolism and/or excretion
- Gastro-intestinal conditions that preclude feeding or affect nutrient absorption (gastroschisis, omphalocele)
- EGA >33 weeks or birth weight >1800 grams or EGA <23 weeks or birth weight <750 grams
- Apgar <3 at 5 minutes
- Grade 3 or higher intraventricular hemorrhage (IVH)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human milk based human milk fortifierA human milk fortifier with added minerals made from donor human milk | Other | Prospective |
Primary outcome
Return to birth weight day
Time frame: birth to 30 days
Day of life infant returns to birth weight
Growth Velocity
Time frame: Weekly until 36 weeks post menstrual age or discharge
rate of weight gain measured as g/kg/day
Mean Serum Magnesium
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Serum and urine Magnesium
Mean Serum CO2
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Serum CO2
11 secondary outcomes
Mean z-scores
Time frame: Weekly until 36 weeks post menstrual age or discharge
Mean serum Vitamin D, 1 25 (OH) 2D
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum parathyroid Hormone (PTH)
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Sodium
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Blood Urea Nitrogen (BUN)
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Calcium
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Phosphorus
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Alkaline Phosphatase
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Hemoglobin
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Potassium
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Mean serum Hematocrit
Time frame: Every 14 days until 36 weeks post menstrual age or discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Background: PubMed 16585322Ehrenkranz 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.
- Background: PubMed 23601190Fenton 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.
- Background: PubMed 22371471Section 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.
- BackgroundKoletsko B PB, Uauy R. Nutritional Care of Preterm Infants. Basel, Switzerland: Karger, 2014.
- Background: PubMed 26488118Kim 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.
- Background: PubMed 22987877Moya 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.
- Background: PubMed 20036378Sullivan 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.
- BackgroundGates A BJ. [Neonatal Outcomes Augusta Univeristy NICU] Unpublished raw data. Augusta 2017.
- Background: PubMed 20732945Stoll 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.
- Background: PubMed 24394538Thoene 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.
- Background: PubMed 28637062Kumar 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.
- Background: PubMed 23968744Cristofalo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Gates, RD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human milk based human milk fortifier in people with Premature Infant and Breast Milk Expression, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to birth weight day (time frame: birth to 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839173, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.