PrematurityNICUNCT01483079
Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU)
An observational study of Prematurity, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Human milk feeding is associated with great benefits to the health and development of infants, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prematurity
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: A cohort of infants less than or equal to 1250 grams birth weight that received donor human milk products in the NICU will be recruited and followed. Some infants recruited will be from a previously studied population of very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital.
Who may be able to join
- Premature infants (<37 weeks gestation) with a birth weight less than or equal to 1250 grams birth weight that received donor human milk products in the NICU during hospitalization.
Who cannot join
- Infants with a birth weight greater than 1250 grams.
- Infants transferred from an outside hospital to TCH at greater than one week of age.
- Infants who do not achieve any enteral feeds by 4 weeks of age.
- Infants with major congenital anomalies.
- Infants who die within the first 48 hours of admission to TCH.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-Discharge Growth and Development of Infants Who Received Donor Human Milk Products in the NICU
Human milk feeding is associated with great benefits to the health and development of infants, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. The use of donor human milk products for very low birth weight infants as an alternative to cow milk has risen dramatically in the past year.
Purpose: To evaluate post-discharge growth and neurodevelopment of infants less than or equal to 1250 grams birth weight receiving an exclusive human milk protein diet.
Read the detailed description
An exclusive human milk protein diet in infants less than 1250 grams birth weight has been shown to reduce the rate of necrotizing enterocolitis, a devastating intestinal disease in premature infants, by 50%. New guidelines were introduced in 2009 at Texas Children's Hospital to outline the appropriate use of donor human milk products.
First, infants from a previous study will be identified and recruited for this study. Other potential subjects (infants) will be identified by the GCRC nursing staff at Texas Childrens Hospital upon admission to the neonatal intensive care unit (NICU) (Levels 2 and 3) and communicated to the PI and PIs staff.
This study includes three visits:
- Outpatient visit at 12 to 15 months corrected gestational age- first outpatient visit to 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), and check hemoglobin and ferritin. Parents will bring their childs labs from the pediatrician or give permission for records to be accessed in Epic if they receive care from Texas Childrens Pediatric Associates. If records are obtained, labs will not be drawn at this visit. Some of the historical information may be obtained via telephone prior to the outpatient visit.
- Outpatient visit at 18 to 22 months corrected gestational age- second outpatient visit for collection of anthropometric data, interim medical history, demographic and socioeconomic information, nutrition history, routine Neurodevelopmental Evaluation as part of standard follow-up for extremely low birth weight infants (The Bayley Scales of Infant Development II) administered by certified testers (trained professional), and whole body dual energy x-ray absorptiometry (DXA) will be performed. Some of the historical information may be obtained via telephone prior to the outpatient visit. We will also obtain the height and weight of mom and dad at this visit.
- Outpatient visit at 5 years of age- third outpatient visit for collection of anthropometric data, interim medical history, demographic and socioeconomic information, nutrition history and developmental evaluation as routine for a school age child. Some of the historical information may be obtained via telephone prior to the outpatient visit.
If infants were not originally followed in the H-26923 study, additional data will be collected from the infants chart for the hospitalization in the NICU. Data collected will include: anthropometrics at birth and discharge, enteral feeding data and parenteral nutrition throughout admission, nutrition related labs, APGAR scores, medications- lasix, chlorothiazide, dopamine, hydrocortisone and dexamethasone, morbidities such as necrotizing enterocolitis, patent ductus arteriosus, spontaneous intestinal perforation, intraventricular hemorrhage, sepsis, and chronic lung disease.
If infants are re-hospitalized or they receive their primary care from a Texas Childrens Pediatrics Associates Clinic, with the consent of the subjects parents, we would collect information from the chart including: interim anthropometric data, interim medical history, nutrition data and history, and nutrition related labs.
No interventions are part of this protocol.
- Conditions
- Prematurity
- Keywords
- donor human milk products, post-discharge, growth, development
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Former preterm infants | A cohort of infants less than or equal to 1250 grams birth weight that received donor human milk products in the NICU will be recruited and followed. Some infants recruited will be from a previously studied population of very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge growth and neurodevelopment
Per the protocol procedures, growth and development will be assessed at each study visit.
Measured: 12-15 months of age
Post-discharge growth and neurodevelopment
Per the protocol procedures, growth and development will be assessed at each study visit.
Measured: 18-22 months of age
Post-discharge growth and neurodevelopment
Per the protocol procedures, growth and development will be assessed at each study visit.
Measured: 5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Prospective
- Enrolment
- 51 participants (actual)
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
- NCT01483079
- Sponsor's protocol ID
- H-29522
- Acronym
- NICU
- Status last verified
- Jan 2026
- First submitted
- 9 Nov 2011
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
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
- Evaluation of Post-Discharge Growth and Development of Infants Who Received Donor Human Milk Products in the NICU
- ClinicalTrials.gov ID
- NCT01483079
- Acronym / sponsor ID
- NICU / H-29522
- Conditions
- Prematurity
- Keywords
- donor human milk products, post-discharge, growth, development
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Dec 2011 (estimated)
- 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.
Human milk feeding is associated with great benefits to the health and development of infants, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. The use of donor human milk products for very low birth weight infants as an alternative to cow milk has risen dramatically in the past year.
Purpose: To evaluate post-discharge growth and neurodevelopment of infants less than or equal to 1250 grams birth weight receiving an exclusive human milk protein diet.
Detailed description
An exclusive human milk protein diet in infants less than 1250 grams birth weight has been shown to reduce the rate of necrotizing enterocolitis, a devastating intestinal disease in premature infants, by 50%. New guidelines were introduced in 2009 at Texas Children's Hospital to outline the appropriate use of donor human milk products.
First, infants from a previous study will be identified and recruited for this study. Other potential subjects (infants) will be identified by the GCRC nursing staff at Texas Childrens Hospital upon admission to the neonatal intensive care unit (NICU) (Levels 2 and 3) and communicated to the PI and PIs staff.
This study includes three visits:
- Outpatient visit at 12 to 15 months corrected gestational age- first outpatient visit to 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), and check hemoglobin and ferritin. Parents will bring their childs labs from the pediatrician or give permission for records to be accessed in Epic if they receive care from Texas Childrens Pediatric Associates. If records are obtained, labs will not be drawn at this visit. Some of the historical information may be obtained via telephone prior to the outpatient visit.
- Outpatient visit at 18 to 22 months corrected gestational age- second outpatient visit for collection of anthropometric data, interim medical history, demographic and socioeconomic information, nutrition history, routine Neurodevelopmental Evaluation as part of standard follow-up for extremely low birth weight infants (The Bayley Scales of Infant Development II) administered by certified testers (trained professional), and whole body dual energy x-ray absorptiometry (DXA) will be performed. Some of the historical information may be obtained via telephone prior to the outpatient visit. We will also obtain the height and weight of mom and dad at this visit.
- Outpatient visit at 5 years of age- third outpatient visit for collection of anthropometric data, interim medical history, demographic and socioeconomic information, nutrition history and developmental evaluation as routine for a school age child. Some of the historical information may be obtained via telephone prior to the outpatient visit.
If infants were not originally followed in the H-26923 study, additional data will be collected from the infants chart for the hospitalization in the NICU. Data collected will include: anthropometrics at birth and discharge, enteral feeding data and parenteral nutrition throughout admission, nutrition related labs, APGAR scores, medications- lasix, chlorothiazide, dopamine, hydrocortisone and dexamethasone, morbidities such as necrotizing enterocolitis, patent ductus arteriosus, spontaneous intestinal perforation, intraventricular hemorrhage, sepsis, and chronic lung disease.
If infants are re-hospitalized or they receive their primary care from a Texas Childrens Pediatrics Associates Clinic, with the consent of the subjects parents, we would collect information from the chart including: interim anthropometric data, interim medical history, nutrition data and history, and nutrition related labs.
No interventions are part of this protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Former preterm infants | – | –A cohort of infants less than or equal to 1250 grams birth weight that received donor human milk products in the NICU will be recruited and followed. Some infants recruited will be from a previously studied population of very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A cohort of infants less than or equal to 1250 grams birth weight that received donor human milk products in the NICU will be recruited and followed. Some infants recruited will be from a previously studied population of very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital.
Key inclusion criteria (1 listed)
- Premature infants (<37 weeks gestation) with a birth weight less than or equal to 1250 grams birth weight that received donor human milk products in the NICU during hospitalization.
Key exclusion criteria (5 listed)
- Infants with a birth weight greater than 1250 grams.
- Infants transferred from an outside hospital to TCH at greater than one week of age.
- Infants who do not achieve any enteral feeds by 4 weeks of age.
- Infants with major congenital anomalies.
- Infants who die within the first 48 hours of admission to TCH.
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
Post-discharge growth and neurodevelopment
Time frame: 12-15 months of age
Per the protocol procedures, growth and development will be assessed at each study visit.
Post-discharge growth and neurodevelopment
Time frame: 18-22 months of age
Per the protocol procedures, growth and development will be assessed at each study visit.
Post-discharge growth and neurodevelopment
Time frame: 5 years of age
Per the protocol procedures, growth and development will be assessed at each study visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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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 Prematurity, 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 1 inclusion and 5 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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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?
Post-discharge growth and neurodevelopment (time frame: 12-15 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.