Premature BirthNCT05515614
Targeted Nutrition for Moderate to Late Preterm Infants
A study testing Targeted Fortification and Enfamil Liquid Human Milk Fortifier in people with Premature Birth and Breastmilk Collection, run by Loma Linda University at 1 site in United States.
Trial summary
This study will be comparing the postnatal growth of moderate to late preterm infants in the Neonatal Intensive Care Unit (NICU) born between gestational ages of 30 weeks 0 days to 35 weeks and 6 days who are receiving enteral feeds of mother's own breast milk using the NICU's standard nutritional fortification… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Breastmilk Collection, Postnatal Growth Restriction
- What is being tested?
- Targeted Fortification and Enfamil Liquid Human Milk Fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 11 May 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Singleton preterm infants
- Between 30 weeks 0 days and 35 weeks and 6 days
- Receiving any amount of mother's breast milk as a form of enteral nutrition
- Mother is ≥ 18 y/o
Who cannot join
- Not receiving any breast milk
- Congenital anomalies or surgical conditions that interfere with enteral feeding
Trial locations and contacts
1 site in 1 country.
About this study
This study will be comparing the postnatal growth of moderate to late preterm infants in the Neonatal Intensive Care Unit (NICU) born between gestational ages of 30 weeks 0 days to 35 weeks and 6 days who are receiving enteral feeds of mother's own breast milk using the NICU's standard nutritional fortification protocol versus a targeted nutritional fortification protocol.
Read the detailed description
Infants in the NICU born between gestational ages 30 weeks 0 days and 35 weeks 6 days will be screened to determine if they are receiving unfortified mother's breast milk for enteral nutrition. Informed consent will be obtained from these lactating mothers for themselves and their infants to participate in the study. Once enrolled in the study, the mother and infant dyad will be randomized using an electronic tool for block randomization into standard fortification arm (control group) or targeted fortification arm (intervention group). Maximum of 100 infants will be assigned to each arm to ensure statistical significance. The physician team, study statisticians, and the mothers will be blinded in their group assignment.
Mothers will be provided with one-on-one teaching (with verbal and written instructions) by the NICU certified lactation consultants or by an authorized, trained study personnel on how to pool their pumped breast milk for 24 hours, referenced as "breast milk pooling." They will also be shown how to prepare a 10 mL sample of the pooled breast milk for analysis. Pooled breast milk will be analyzed for macronutrient content (protein, carbohydrate, fat, and calories) using Miris Human Milk Analyzer before fortification once a week for both arms of the study. All infants in both groups will follow the enteral feeding advancement schedule until the infant is ready for nutritional fortification.
In the standard fortification arm (control group), mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by Loma Linda University Children's Hospital Neonatal Intensive Care Unit. The feeding protocol, specific to birth weight, is available online in the LLUCH NICU Manual.
In the targeted fortification arm (intervention group), mother's breast milk will be fortified in modular fashion. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. For lipid supplementation, safflower oil will be utilized. Fortification goals for this group will follow the macronutrient intake recommendations for preterm infants published by the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition in 2009. The goal energy level will be between 110 - 135 kcal/kg/day, goal protein level between 3.5 - 4.5 g/kg/day, goal lipid level between 4.8 - 6.6 g/kg/day, and goal carbohydrate level between 11.6 - 13.2 g/kg/day. The goal total daily fluid volume will be between 150 to 180 mL/kg/day.
NICU Registered Dietitians will be provided with the macronutrient contents of pooled breast milk from mothers of babies in the intervention group. Using the aforementioned values from ESPGHAN guideline for each macronutrient, they will provide recommendations on specific amounts of modular supplementation to be added to the pooled breast milk. Based on these recommendations, all un-pooled expressed breast milk of mothers in the intervention group will be fortified in a customized manner by the milk technicians in the NICU milk room and given to infants in the intervention group. NICU Registered Dieticians will not be provided with analysis results showing macronutrient levels of the pooled milk or standard fortified milk in the control group as the current standard of care at LLUCH NICU does not include macronutrient analysis of pooled breast milk for babies born >30 weeks gestation.
Infants enrolled in both arms will have their anthropometric measurements taken once a week from birth to NICU discharge. Anthropometric measurements will include weight, height, and head circumference. The Z-scores of weight, height, and head circumference will be recorded and analyzed for any statistical differences.
- Being tested
- Targeted Fortification, Enfamil Liquid Human Milk Fortifier
- Keywords
- Moderate Preterm, Late Preterm, Postnatal growth, Human milk fortification, Human milk analysis, Targeted nutrition
- 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.
Targeted FortificationDietary supplement
Mother's breast milk will be fortified in modular fashion based on the level of macronutrients (protein, carbohydrate, and fat) found from analysis using the Miris Human Milk Analyser. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. Mother's breast milk will be fortified in modular fashion. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. For lipid supplementation, safflower oil will be utilized. We will set our goal energy level between 110 - 135 kcal/kg/day, protein level between 3.5 - 4.5 g/kg/day, lipid level between 4.8 - 6.6 g/kg/day, and carbohydrate level between 11.6 - 13.2 g/kg/day. We will regard daily fluid volume to be between 150 to 180 mL/kg/day.
Enfamil Liquid Human Milk FortifierDietary supplement
Also called LHMF
Mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier as per standard feeding protocol defined by LLUCH NICU manual.
| Study group | Role | What they receive |
|---|---|---|
| Standard Fortification | Active comparator | Mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by LLUCH NICU. Receives: Dietary Supplement: Enfamil Liquid Human Milk Fortifier |
| Targeted Fortification | Experimental | Mother's breast milk will be fortified with modular additives, namely Amino Acid powder, PolyCal, and safflower oil to meet the individual nutritional needs. Receives: Dietary Supplement: Targeted Fortification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postnatal growth in weight
Weight in kilograms
Measured: From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Postnatal growth in length
Length in centimeters
Measured: From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Postnatal growth in head circumference
Head circumference in centimeters
Measured: From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Protein level in mother's expressed breastmilk
Weekly analysis of pooled mother's expressed breast milk to assess for protein level, measured in grams per 100 milliliters
Measured: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Calories in mother's expressed breastmilk
Weekly analysis of pooled mother's expressed breast milk to assess for amount of calories, measured in kilocalories per 100 milliliters
Measured: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Fat content in mother's expressed breastmilk
Weekly analysis of pooled mother's expressed breast milk to assess for fat content, measured in grams per 100 milliliters
Measured: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Carbohydrate level in mother's expressed breastmilk
Weekly analysis of pooled mother's expressed breast milk to assess for carbohydrate level, measured in grams per 100 milliliters
Measured: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start17 Aug 2022
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Standard nutritional fortification arm (control group): mother's expressed breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by LLUCH NICU Manual. In targeted fortification arm (intervention group), mother's expressed breast milk will be fortified with modular components, Amino Acid power, PolyCal and safflower oil, to meet the individual nutritional needs as determined by NICU dieticians.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raylene Phillips, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515614
- Sponsor's protocol ID
- 5220169
- Status last verified
- Feb 2025
- First submitted
- 19 Aug 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shapiro-Mendoza CK, Tomashek KM, Kotelchuck M, Barfield W, Nannini A, Weiss J, Declercq E. Effect of late-preterm birth and maternal medical conditions on newborn morbidity risk. Pediatrics. 2008 Feb;121(2):e223-32. doi: 10.1542/peds.2006-3629.
PubMed 18245397Radtke JV. The paradox of breastfeeding-associated morbidity among late preterm infants. J Obstet Gynecol Neonatal Nurs. 2011 Jan-Feb;40(1):9-24. doi: 10.1111/j.1552-6909.2010.01211.x.
PubMed 21244492Al-Theyab NA, Donovan TJ, Eiby YA, Colditz PB, Lingwood BE. Fat trajectory after birth in very preterm infants mimics healthy term infants. Pediatr Obes. 2019 Mar;14(3):e12472. doi: 10.1111/ijpo.12472. Epub 2018 Sep 26.
PubMed 30257276Chmielewska A, Farooqi A, Domellof M, Ohlund I. Lean Tissue Deficit in Preterm Infants Persists up to 4 Months of Age: Results from a Swedish Longitudinal Study. Neonatology. 2020;117(1):80-87. doi: 10.1159/000503292. Epub 2019 Dec 10.
PubMed 31822002Rochow N, Fusch G, Ali A, Bhatia A, So HY, Iskander R, Chessell L, El Helou S, Fusch C. Individualized target fortification of breast milk with protein, carbohydrates, and fat for preterm infants: A double-blind randomized controlled trial. Clin Nutr. 2021 Jan;40(1):54-63. doi: 10.1016/j.clnu.2020.04.031. Epub 2020 May 6.
PubMed 32446787Chou FS, Yeh HW. Sex differences in postnatal weight gain trajectories of extremely preterm newborns. J Perinatol. 2021 Aug;41(8):1835-1844. doi: 10.1038/s41372-021-01099-2. Epub 2021 May 25.
PubMed 34035451Agostoni 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 19881390
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Nutrition for Moderate to Late Preterm Infants
- ClinicalTrials.gov ID
- NCT05515614
- Acronym / sponsor ID
- 5220169
- Keywords
- Moderate Preterm, Late Preterm, Postnatal growth, Human milk fortification, Human milk analysis, Targeted nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 25 Aug 2022 (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.
This study will be comparing the postnatal growth of moderate to late preterm infants in the Neonatal Intensive Care Unit (NICU) born between gestational ages of 30 weeks 0 days to 35 weeks and 6 days who are receiving enteral feeds of mother's own breast milk using the NICU's standard nutritional fortification protocol versus a targeted nutritional fortification protocol.
Detailed description
Infants in the NICU born between gestational ages 30 weeks 0 days and 35 weeks 6 days will be screened to determine if they are receiving unfortified mother's breast milk for enteral nutrition. Informed consent will be obtained from these lactating mothers for themselves and their infants to participate in the study. Once enrolled in the study, the mother and infant dyad will be randomized using an electronic tool for block randomization into standard fortification arm (control group) or targeted fortification arm (intervention group). Maximum of 100 infants will be assigned to each arm to ensure statistical significance. The physician team, study statisticians, and the mothers will be blinded in their group assignment.
Mothers will be provided with one-on-one teaching (with verbal and written instructions) by the NICU certified lactation consultants or by an authorized, trained study personnel on how to pool their pumped breast milk for 24 hours, referenced as "breast milk pooling." They will also be shown how to prepare a 10 mL sample of the pooled breast milk for analysis. Pooled breast milk will be analyzed for macronutrient content (protein, carbohydrate, fat, and calories) using Miris Human Milk Analyzer before fortification once a week for both arms of the study. All infants in both groups will follow the enteral feeding advancement schedule until the infant is ready for nutritional fortification.
In the standard fortification arm (control group), mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by Loma Linda University Children's Hospital Neonatal Intensive Care Unit. The feeding protocol, specific to birth weight, is available online in the LLUCH NICU Manual.
In the targeted fortification arm (intervention group), mother's breast milk will be fortified in modular fashion. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. For lipid supplementation, safflower oil will be utilized. Fortification goals for this group will follow the macronutrient intake recommendations for preterm infants published by the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition in 2009. The goal energy level will be between 110 - 135 kcal/kg/day, goal protein level between 3.5 - 4.5 g/kg/day, goal lipid level between 4.8 - 6.6 g/kg/day, and goal carbohydrate level between 11.6 - 13.2 g/kg/day. The goal total daily fluid volume will be between 150 to 180 mL/kg/day.
NICU Registered Dietitians will be provided with the macronutrient contents of pooled breast milk from mothers of babies in the intervention group. Using the aforementioned values from ESPGHAN guideline for each macronutrient, they will provide recommendations on specific amounts of modular supplementation to be added to the pooled breast milk. Based on these recommendations, all un-pooled expressed breast milk of mothers in the intervention group will be fortified in a customized manner by the milk technicians in the NICU milk room and given to infants in the intervention group. NICU Registered Dieticians will not be provided with analysis results showing macronutrient levels of the pooled milk or standard fortified milk in the control group as the current standard of care at LLUCH NICU does not include macronutrient analysis of pooled breast milk for babies born >30 weeks gestation.
Infants enrolled in both arms will have their anthropometric measurements taken once a week from birth to NICU discharge. Anthropometric measurements will include weight, height, and head circumference. The Z-scores of weight, height, and head circumference will be recorded and analyzed for any statistical differences.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Standard nutritional fortification arm (control group): mother's expressed breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by LLUCH NICU Manual. In targeted fortification arm (intervention group), mother's expressed breast milk will be fortified with modular components, Amino Acid power, PolyCal and safflower oil, to meet the individual nutritional needs as determined by NICU dieticians.
| Arm | Type | Receives |
|---|---|---|
| Standard Fortification | Active comparator | Dietary Supplement: Enfamil Liquid Human Milk FortifierMother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by LLUCH NICU. |
| Targeted Fortification | Experimental | Dietary Supplement: Targeted FortificationMother's breast milk will be fortified with modular additives, namely Amino Acid powder, PolyCal, and safflower oil to meet the individual nutritional needs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton preterm infants
- Between 30 weeks 0 days and 35 weeks and 6 days
- Receiving any amount of mother's breast milk as a form of enteral nutrition
- Mother is ≥ 18 y/o
Key exclusion criteria (2 listed)
- Not receiving any breast milk
- Congenital anomalies or surgical conditions that interfere with enteral feeding
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 |
|---|---|---|
| Targeted FortificationMother's breast milk will be fortified in modular fashion based on the level of macronutrients (protein, carbohydrate, and fat) found from analysis using the Miris Human Milk Analyser. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. Mother's breast milk will be fortified in modular fashion. For protein supplementation, Amino Acid powder will be utilized as a modular component. For carbohydrate supplementation, PolyCal will be utilized. For lipid supplementation, safflower oil will be utilized. We will set our goal energy level between 110 - 135 kcal/kg/day, protein level between 3.5 - 4.5 g/kg/day, lipid level between 4.8 - 6.6 g/kg/day, and carbohydrate level between 11.6 - 13.2 g/kg/day. We will regard daily fluid volume to be between 150 to 180 mL/kg/day. | Dietary supplement | Targeted Fortification |
| Enfamil Liquid Human Milk FortifierAlso: LHMFMother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier as per standard feeding protocol defined by LLUCH NICU manual. | Dietary supplement | Standard Fortification |
Primary outcome
Postnatal growth in weight
Time frame: From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Weight in kilograms
Postnatal growth in length
Time frame: From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Length in centimeters
Postnatal growth in head circumference
Time frame: From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Head circumference in centimeters
Protein level in mother's expressed breastmilk
Time frame: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Weekly analysis of pooled mother's expressed breast milk to assess for protein level, measured in grams per 100 milliliters
Calories in mother's expressed breastmilk
Time frame: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Weekly analysis of pooled mother's expressed breast milk to assess for amount of calories, measured in kilocalories per 100 milliliters
Fat content in mother's expressed breastmilk
Time frame: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Weekly analysis of pooled mother's expressed breast milk to assess for fat content, measured in grams per 100 milliliters
Carbohydrate level in mother's expressed breastmilk
Time frame: From date of first breast milk analysis to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Weekly analysis of pooled mother's expressed breast milk to assess for carbohydrate level, measured in grams per 100 milliliters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 18245397Shapiro-Mendoza CK, Tomashek KM, Kotelchuck M, Barfield W, Nannini A, Weiss J, Declercq E. Effect of late-preterm birth and maternal medical conditions on newborn morbidity risk. Pediatrics. 2008 Feb;121(2):e223-32. doi: 10.1542/peds.2006-3629.
- Background: PubMed 21244492Radtke JV. The paradox of breastfeeding-associated morbidity among late preterm infants. J Obstet Gynecol Neonatal Nurs. 2011 Jan-Feb;40(1):9-24. doi: 10.1111/j.1552-6909.2010.01211.x.
- Background: PubMed 30257276Al-Theyab NA, Donovan TJ, Eiby YA, Colditz PB, Lingwood BE. Fat trajectory after birth in very preterm infants mimics healthy term infants. Pediatr Obes. 2019 Mar;14(3):e12472. doi: 10.1111/ijpo.12472. Epub 2018 Sep 26.
- Background: PubMed 31822002Chmielewska A, Farooqi A, Domellof M, Ohlund I. Lean Tissue Deficit in Preterm Infants Persists up to 4 Months of Age: Results from a Swedish Longitudinal Study. Neonatology. 2020;117(1):80-87. doi: 10.1159/000503292. Epub 2019 Dec 10.
- Background: PubMed 32446787Rochow N, Fusch G, Ali A, Bhatia A, So HY, Iskander R, Chessell L, El Helou S, Fusch C. Individualized target fortification of breast milk with protein, carbohydrates, and fat for preterm infants: A double-blind randomized controlled trial. Clin Nutr. 2021 Jan;40(1):54-63. doi: 10.1016/j.clnu.2020.04.031. Epub 2020 May 6.
- Background: PubMed 34035451Chou FS, Yeh HW. Sex differences in postnatal weight gain trajectories of extremely preterm newborns. J Perinatol. 2021 Aug;41(8):1835-1844. doi: 10.1038/s41372-021-01099-2. Epub 2021 May 25.
- Background: PubMed 19881390Agostoni 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.
- 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.
Raylene Phillips, MD principal investigator
Loma Linda 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 Targeted Fortification and Enfamil Liquid Human Milk Fortifier in people with Premature Birth and Breastmilk Collection, run by Loma Linda 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 24 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postnatal growth in weight (time frame: From date of birth to date of NICU discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months). The study lists 7 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 NCT05515614, which also lists 7 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 24 Feb 2025.