Premature InfantsNCT04190875
Post-Discharge Growth and Development of Infants Who Received Targeted Fortification in the NICU
An observational study of Premature Infants, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Extremely low birth weight (ELBW) infants are at risk for slow growth, metabolic abnormalities, and poor neurodevelopmental outcomes. Postnatal growth standards are based on estimated intrauterine growth from historical cohort studies and post-mortem analyses. Read more about this study
- Who is it for?
- Ages 18 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Infants
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2019to 1 Feb 2027
- Phase
- Observational
- 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 18 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children 18-24 months corrected age, who participated in an earlier study H-38611. These children were either born at Texas Children's Hospital in the first 24 hours of life and admitted to our Neonatal Intensive Care Unit. These infants had a birth weight of less than or equal to 1000 grams and were randomized to receive a standard protein diet (3.5-3.8 grams of protein per kilogram of body weight) or a high protein diet (4.2-4.5 grams of protein per kilogram of body weight). Infants in both groups received recommended clinical guidelines for protein.
Who may be able to join
- Children born prematurely, with birth weight of less than or equal to 1000 grams
- Born at Texas Children's Hospital or transferred to the Neonatal Intensive Care Unit from another hospital in the first 24 hours of life
- Completed a previous study (H-38611) in which the child received targeted protein fortification with donor human milk products
Who cannot join
- Infants not previously enrolled in a previous study (H-38611) in the Neonatal Intensive Care Unit at Texas Children's Hospital
- Infants enrolled in but did not complete a previous study (H-38611) in the Neonatal Intensive Care Unit at Texas Children's Hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Post-Discharge Growth and Development of Infants Who Received Targeted Fortification (High Versus Standard Protein Diet) in the NICU
Extremely low birth weight (ELBW) infants are at risk for slow growth, metabolic abnormalities, and poor neurodevelopmental outcomes. Postnatal growth standards are based on estimated intrauterine growth from historical cohort studies and post-mortem analyses. Despite current strategies aimed at appropriate nutrition, a large proportion of these infants have postnatal growth failure (anthropometric values < 10th percentile) reported in the literature as high as 89-99%. More recent data shows lower rates of postnatal growth failure but further improvement is still needed. Adequate growth is key to ensuring improved neurodevelopment and other outcomes.
The investigators are currently evaluating the effects of a high versus standard protein enteral diet on growth and body composition in infants less than or equal to 1000 grams birth weight in the Neonatal Intensive Care Unit. (H-38611). Infants less than or equal to 1000 grams birth weight are provided an enteral diet with a level of protein based on individual caloric and protein analysis of human milk also known as targeted fortification. The standard protein diet provides 3.5-3.8 g/kg/day of protein, while the high protein diet provides 4.2-4.5 g/kg/day.
Read more
The investigators have shown that infants who receive this diet achieve growth at targeted standards. As this diet is well tolerated and associated with improved outcomes in our highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Body composition in these infants receiving targeted fortification is being evaluated at 35-36 weeks post menstrual age.
Because these infants are at such high risk for poor growth and neurodevelopment, it is important to investigate the impact of a higher protein exclusive human milk diet on long-term neurodevelopmental outcomes, body composition, and growth at 18-24 months.
Read the detailed description
The investigators plan to evaluate the effects of a high versus standard protein enteral diet utilizing targeted fortification on neurodevelopmental outcomes, growth, and body composition at 18-24 months in infants with a birth weight of less than or equal to 1000 grams.
Children who have completed a previous study (H-38611) evaluating the effects of a high versus standard protein diet utilizing targeted fortification with human donor milk products on weight, length, and body composition will be recruited for this study.
Infants in the previous study, (H-38611) were either born at Texas Children's Hospital or transferred to Texas Children's Hospital in the first 24 hours of life and admitted to our Neonatal Intensive Care Unit. These infants had a birth weight of less than or equal to 1000 grams and were randomized to receive a standard protein diet (3.5-3.8 grams of protein per kilogram of body weight- the amount of protein recommended for premature babies by the American Academy of Pediatrics ) or a high protein diet (4.2-4.5 grams of protein per kilogram of body weight- the amount of protein recommended for premature babies by the European Society of Paediatric Gastroenterolgy, Hepatology, and Nutrition). Infants in both groups received recommended clinical guidelines for protein.
While the previous study (H-38611) evaluated the effects of a high versus standard protein diet on weight, length and body composition prior to discharge from the Neonatal Intensive Care Unit, this study (H-44733) will assess if the amount of protein in the diet the infant received impacted growth, body composition, and neurodevelopment at 18-24 months of life.
For the study (H-44733), parents of patients who completed H-38611 will be consented prior to discharge from the Neonatal Intensive Care Unit. For patients who completed the previous study (H-38611) and have been discharged, the investigators will contact the parents by telephone. The investigators will mail a consent form to parents interested in having their child complete the follow-up study (H-44733) so they can review the consent form. Then, if they want to participate in the study, they will contact study staff to schedule an appointment. At the beginning of the appointment study staff will obtain informed verbal and written consent in order to conduct study visit.
This study includes an outpatient visit at 18-24 months corrected gestational age. At the visit, the investigators will obtain baseline anthropometric data, interim medical history, demographic and socioeconomic information, and nutrition history of the child since discharge (formula, human milk, vitamins, and medications). A registered dietitian will ask parents questions about the child's current diet.
Next, body composition will be measured by whole body dual energy x-ray absorptiometry or DXA scan. DXA scan is the current gold standard to provide lean and fat body mass and bone mineral content results. DXA is a way to measure bone mineral density, or the amount of calcium and other minerals in the bones.
In addition, a Neurodevelopmental Evaluation as part of standard follow-up for extremely low birth weight infants (The Bayley Scales of Infant and Toddler Development, 3rd Edition) will be completed. The Bayley Scales of Infant and Toddler Development is used mainly to assess the mental and motor development of infants and toddlers, ages 1-42 months. It will be administered by a pediatric developmental physician.
Results of evaluations will be given to parents and recommendations for follow-up will be made by the physician completing the evaluation.
No interventions are part of this protocol.
- Conditions
- Premature Infants
- Keywords
- Standard Protein Diet, High Protein Diet, Targeted Fortification, Post-Discharge Growth, Post-Discharge Body Compostion, Post-Discharge Neurodevelopment, Protein, Human Milk Diet, Prematurity
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear growth measured using a pediatric stadiometer
Linear growth will be measured in centimeters (cm) at the time of the outpatient visit for DXA scan.
Measured: 18-24 months corrected age
Secondary outcomes (2)
Body composition measured by dual-energy x-ray absorptiometry (DXA)
The subject will be scanned once in infant mode and once in adult mode during the time of the outpatient visit.
Measured: 18-24 months corrected age
Neurodevelopment will be measured by administration of The Bayley Scales of Infant and Toddler Development, 3rd Edition
A developmental pediatrician will administer The Bayley Scales of Infant and Toddler Development at the time of the outpatient visit. This assessment consists of a series of developmental play tasks and takes between 45-60 minutes to administer and derives a developmental quotient. The measure consists of five scales. Raw scores of successfully completed items are converted to scale scores and to composite scores. Low/high scores for each scale are as following: Cognitive (55-145), Language (47-153), Motor (46-154), Social-Emotional (55-145). Children who score low on this assessment are at risk for future developmental problems.
Measured: 18-24 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start20 Feb 2019
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Why it stopped: Inability to bring patients in for follow-up visits due to institutional restrictions related to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Hair, Baylor College of Medicine
- Investigators
- Amy B Hair, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190875
- Sponsor's protocol ID
- H-44733
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2019
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hair AB, Peluso AM, Hawthorne KM, Perez J, Smith DP, Khan JY, O'Donnell A, Powers RJ, Lee ML, Abrams SA. Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet. Breastfeed Med. 2016 Mar;11(2):70-4. doi: 10.1089/bfm.2015.0134. Epub 2016 Jan 20.
PubMed 26789484Hair AB, Blanco CL, Moreira AG, Hawthorne KM, Lee ML, Rechtman DJ, Abrams SA. Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. J Pediatr. 2014 Nov;165(5):915-20. doi: 10.1016/j.jpeds.2014.07.005. Epub 2014 Aug 15.
PubMed 25130571Hair AB, Hawthorne KM, Chetta KE, Abrams SA. Human milk feeding supports adequate growth in infants </= 1250 grams birth weight. BMC Res Notes. 2013 Nov 13;6:459. doi: 10.1186/1756-0500-6-459.
PubMed 24220185
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Discharge Growth and Development of Infants Who Received Targeted Fortification (High Versus Standard Protein Diet) in the NICU
- ClinicalTrials.gov ID
- NCT04190875
- Acronym / sponsor ID
- H-44733
- Conditions
- Premature Infants
- Keywords
- Standard Protein Diet, High Protein Diet, Targeted Fortification, Post-Discharge Growth, Post-Discharge Body Compostion, Post-Discharge Neurodevelopment, Protein, Human Milk Diet
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Inability to bring patients in for follow-up visits due to institutional restrictions related to COVID-19
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 Dec 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.
Extremely low birth weight (ELBW) infants are at risk for slow growth, metabolic abnormalities, and poor neurodevelopmental outcomes. Postnatal growth standards are based on estimated intrauterine growth from historical cohort studies and post-mortem analyses. Despite current strategies aimed at appropriate nutrition, a large proportion of these infants have postnatal growth failure (anthropometric values < 10th percentile) reported in the literature as high as 89-99%. More recent data shows lower rates of postnatal growth failure but further improvement is still needed. Adequate growth is key to ensuring improved neurodevelopment and other outcomes.
The investigators are currently evaluating the effects of a high versus standard protein enteral diet on growth and body composition in infants less than or equal to 1000 grams birth weight in the Neonatal Intensive Care Unit. (H-38611). Infants less than or equal to 1000 grams birth weight are provided an enteral diet with a level of protein based on individual caloric and protein analysis of human milk also known as targeted fortification. The standard protein diet provides 3.5-3.8 g/kg/day of protein, while the high protein diet provides 4.2-4.5 g/kg/day.
The investigators have shown that infants who receive this diet achieve growth at targeted standards. As this diet is well tolerated and associated with improved outcomes in our highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Body composition in these infants receiving targeted fortification is being evaluated at 35-36 weeks post menstrual age.
Because these infants are at such high risk for poor growth and neurodevelopment, it is important to investigate the impact of a higher protein exclusive human milk diet on long-term neurodevelopmental outcomes, body composition, and growth at 18-24 months.
Detailed description
The investigators plan to evaluate the effects of a high versus standard protein enteral diet utilizing targeted fortification on neurodevelopmental outcomes, growth, and body composition at 18-24 months in infants with a birth weight of less than or equal to 1000 grams.
Children who have completed a previous study (H-38611) evaluating the effects of a high versus standard protein diet utilizing targeted fortification with human donor milk products on weight, length, and body composition will be recruited for this study.
Infants in the previous study, (H-38611) were either born at Texas Children's Hospital or transferred to Texas Children's Hospital in the first 24 hours of life and admitted to our Neonatal Intensive Care Unit. These infants had a birth weight of less than or equal to 1000 grams and were randomized to receive a standard protein diet (3.5-3.8 grams of protein per kilogram of body weight- the amount of protein recommended for premature babies by the American Academy of Pediatrics ) or a high protein diet (4.2-4.5 grams of protein per kilogram of body weight- the amount of protein recommended for premature babies by the European Society of Paediatric Gastroenterolgy, Hepatology, and Nutrition). Infants in both groups received recommended clinical guidelines for protein.
While the previous study (H-38611) evaluated the effects of a high versus standard protein diet on weight, length and body composition prior to discharge from the Neonatal Intensive Care Unit, this study (H-44733) will assess if the amount of protein in the diet the infant received impacted growth, body composition, and neurodevelopment at 18-24 months of life.
For the study (H-44733), parents of patients who completed H-38611 will be consented prior to discharge from the Neonatal Intensive Care Unit. For patients who completed the previous study (H-38611) and have been discharged, the investigators will contact the parents by telephone. The investigators will mail a consent form to parents interested in having their child complete the follow-up study (H-44733) so they can review the consent form. Then, if they want to participate in the study, they will contact study staff to schedule an appointment. At the beginning of the appointment study staff will obtain informed verbal and written consent in order to conduct study visit.
This study includes an outpatient visit at 18-24 months corrected gestational age. At the visit, the investigators will obtain baseline anthropometric data, interim medical history, demographic and socioeconomic information, and nutrition history of the child since discharge (formula, human milk, vitamins, and medications). A registered dietitian will ask parents questions about the child's current diet.
Next, body composition will be measured by whole body dual energy x-ray absorptiometry or DXA scan. DXA scan is the current gold standard to provide lean and fat body mass and bone mineral content results. DXA is a way to measure bone mineral density, or the amount of calcium and other minerals in the bones.
In addition, a Neurodevelopmental Evaluation as part of standard follow-up for extremely low birth weight infants (The Bayley Scales of Infant and Toddler Development, 3rd Edition) will be completed. The Bayley Scales of Infant and Toddler Development is used mainly to assess the mental and motor development of infants and toddlers, ages 1-42 months. It will be administered by a pediatric developmental physician.
Results of evaluations will be given to parents and recommendations for follow-up will be made by the physician completing the evaluation.
No interventions are part of this protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 18-24 months corrected age, who participated in an earlier study H-38611. These children were either born at Texas Children's Hospital in the first 24 hours of life and admitted to our Neonatal Intensive Care Unit. These infants had a birth weight of less than or equal to 1000 grams and were randomized to receive a standard protein diet (3.5-3.8 grams of protein per kilogram of body weight) or a high protein diet (4.2-4.5 grams of protein per kilogram of body weight). Infants in both groups received recommended clinical guidelines for protein.
Key inclusion criteria (3 listed)
- Children born prematurely, with birth weight of less than or equal to 1000 grams
- Born at Texas Children's Hospital or transferred to the Neonatal Intensive Care Unit from another hospital in the first 24 hours of life
- Completed a previous study (H-38611) in which the child received targeted protein fortification with donor human milk products
Key exclusion criteria (2 listed)
- Infants not previously enrolled in a previous study (H-38611) in the Neonatal Intensive Care Unit at Texas Children's Hospital
- Infants enrolled in but did not complete a previous study (H-38611) in the Neonatal Intensive Care Unit at Texas Children's Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Linear growth measured using a pediatric stadiometer
Time frame: 18-24 months corrected age
Linear growth will be measured in centimeters (cm) at the time of the outpatient visit for DXA scan.
2 secondary outcomes
Body composition measured by dual-energy x-ray absorptiometry (DXA)
Time frame: 18-24 months corrected age
Neurodevelopment will be measured by administration of The Bayley Scales of Infant and Toddler Development, 3rd Edition
Time frame: 18-24 months corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Background: PubMed 26789484Hair AB, Peluso AM, Hawthorne KM, Perez J, Smith DP, Khan JY, O'Donnell A, Powers RJ, Lee ML, Abrams SA. Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet. Breastfeed Med. 2016 Mar;11(2):70-4. doi: 10.1089/bfm.2015.0134. Epub 2016 Jan 20.
- Background: PubMed 25130571Hair AB, Blanco CL, Moreira AG, Hawthorne KM, Lee ML, Rechtman DJ, Abrams SA. Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. J Pediatr. 2014 Nov;165(5):915-20. doi: 10.1016/j.jpeds.2014.07.005. Epub 2014 Aug 15.
- Background: PubMed 24220185Hair AB, Hawthorne KM, Chetta KE, Abrams SA. Human milk feeding supports adequate growth in infants </= 1250 grams birth weight. BMC Res Notes. 2013 Nov 13;6:459. doi: 10.1186/1756-0500-6-459.
- 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 B Hair, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infants, run by Baylor College of Medicine 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 3 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: paused, as of the sponsor's last update on 29 Jan 2026. 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?
Linear growth measured using a pediatric stadiometer (time frame: 18-24 months corrected age). 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 NCT04190875, which also lists 3 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 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.