Infant, Very Low Birth WeightNICUNCT01204983
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU
An observational study of Infant, Very Low Birth Weight, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Human milk is associated with substantial benefits to infants' health and development, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. The use of donor human milk as an alternative to cow milk in these infants has risen dramatically in the past year. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Infant, Very Low Birth Weight
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2010to 31 Dec 2025
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Premature, very low birth weight infants only
Who may be able to join
- Premature infants (<37 weeks gestation) with a birth weight less than or equal to 1250 grams.
Who cannot join
- Infants with a birth weight greater than 1250 grams
- Infants transferred from an outside hospital to TCH at greater than 21 days of age
- Infants who do not achieve any enteral feeds by 4 weeks of age
- Infants with major congenital anomalies
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: Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices With Donor Human Milk Products in the NICU
Human milk is associated with substantial benefits to infants' health and development, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. The use of donor human milk as an alternative to cow milk in these infants has risen dramatically in the past year. However, there have been recent reports of hyperphosphatemia and hyponatremia associated with the consumption of donor human milk products. These electrolyte imbalances can lead to concerning symptoms, including headache, nausea, vomiting, altered mental status, coma, seizures, or heart failure. It is important to recognize and appropriately treat these electrolyte disturbances associated with donor human milk to avoid potential nutritional problems.
Read the detailed description
This is a quality improvement project to evaluate the current standard of care of nutritional management for very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital.
There is no randomization, there are no control subjects, and therefore there is no probability of group assignment.
Infants will be identified by the dietitian staff at TCH upon admission to the NICU (Levels 2 and 3) and communicated to the PI and PI's staff.
For each subject, data collection will begin at the point that the infant first receives any enteral feeding (including trophic feeds). All infants less than or equal to 1250 g birth weight will be followed initially. If the parent declines to allow donor human milk products for the infant, this will be noted in the data collection and no additional data will be collected for this infant. If at a later time, the parent decides to allow donor human milk products, we will begin data collection again. Our current experience is that >95% of mothers agree to donor human milk products.
Data collection will continue throughout the hospitalization until one week after all donor human milk products have been discontinued or discharge.
From the medical chart, we will record the following data on a weekly basis: weight, length, head circumference, labs (Chem 10 panel - BUN, creatinine, sodium, potassium, bicarbonate, chloride, calcium, phosphorus, magnesium, and glucose), medications, and the nutrition order (parenteral and enteral nutrition feeding orders including volume, concentration, and additives). If an abnormal nutrition-related lab is noted, changes in the nutrition order will be recorded more frequently than on a weekly basis. A copy of the data collection template is attached in Section S.
No labs will be requested for research purposes. No interventions are part of this protocol. This protocol involves only minimal risk to individuals. A waiver of consent would not in any way adversely affect the privacy rights and the welfare of the individuals.
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- very low birth weight infant, donor human milk
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 |
|---|---|---|
| Observational | This is a quality improvement project to evaluate the current standard of care of nutritional management for very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital. There is no randomization, there are no control subjects, and therefore there is no probability of group assignment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the current standard of care of nutritional management
To evaluate the current standard of care of nutritional management for very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital.
Measured: August 2010 - December 2011
Secondary outcomes (1)
To ensure that guidelines for VLBW infants are followed
To ensure that guidelines to monitor electrolytes in infants < 1250 g receiving donor human milk products are being followed and that appropriate interventions are being given if abnormalities are determined.
Measured: August 2010 - December 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study start1 Jul 2010
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Very Low Birth WeightStudies 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
- 150 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 Hair, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204983
- Sponsor's protocol ID
- H-26923
- Acronym
- NICU
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2010
- 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
- Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices With Donor Human Milk Products in the NICU
- ClinicalTrials.gov ID
- NCT01204983
- Acronym / sponsor ID
- NICU / H-26923
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- very low birth weight infant, donor human milk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Sep 2010 (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 is associated with substantial benefits to infants' health and development, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant. The use of donor human milk as an alternative to cow milk in these infants has risen dramatically in the past year. However, there have been recent reports of hyperphosphatemia and hyponatremia associated with the consumption of donor human milk products. These electrolyte imbalances can lead to concerning symptoms, including headache, nausea, vomiting, altered mental status, coma, seizures, or heart failure. It is important to recognize and appropriately treat these electrolyte disturbances associated with donor human milk to avoid potential nutritional problems.
Detailed description
This is a quality improvement project to evaluate the current standard of care of nutritional management for very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital.
There is no randomization, there are no control subjects, and therefore there is no probability of group assignment.
Infants will be identified by the dietitian staff at TCH upon admission to the NICU (Levels 2 and 3) and communicated to the PI and PI's staff.
For each subject, data collection will begin at the point that the infant first receives any enteral feeding (including trophic feeds). All infants less than or equal to 1250 g birth weight will be followed initially. If the parent declines to allow donor human milk products for the infant, this will be noted in the data collection and no additional data will be collected for this infant. If at a later time, the parent decides to allow donor human milk products, we will begin data collection again. Our current experience is that >95% of mothers agree to donor human milk products.
Data collection will continue throughout the hospitalization until one week after all donor human milk products have been discontinued or discharge.
From the medical chart, we will record the following data on a weekly basis: weight, length, head circumference, labs (Chem 10 panel - BUN, creatinine, sodium, potassium, bicarbonate, chloride, calcium, phosphorus, magnesium, and glucose), medications, and the nutrition order (parenteral and enteral nutrition feeding orders including volume, concentration, and additives). If an abnormal nutrition-related lab is noted, changes in the nutrition order will be recorded more frequently than on a weekly basis. A copy of the data collection template is attached in Section S.
No labs will be requested for research purposes. No interventions are part of this protocol. This protocol involves only minimal risk to individuals. A waiver of consent would not in any way adversely affect the privacy rights and the welfare of the individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –This is a quality improvement project to evaluate the current standard of care of nutritional management for very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital. There is no randomization, there are no control subjects, and therefore there is no probability of group assignment. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Premature, very low birth weight infants only
Key inclusion criteria (1 listed)
- Premature infants (<37 weeks gestation) with a birth weight less than or equal to 1250 grams.
Key exclusion criteria (4 listed)
- Infants with a birth weight greater than 1250 grams
- Infants transferred from an outside hospital to TCH at greater than 21 days of age
- Infants who do not achieve any enteral feeds by 4 weeks of age
- Infants with major congenital anomalies
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
To evaluate the current standard of care of nutritional management
Time frame: August 2010 - December 2011
To evaluate the current standard of care of nutritional management for very low birth weight infants receiving donor human milk products in the NICU at Texas Children's Hospital.
1 secondary outcome
To ensure that guidelines for VLBW infants are followed
Time frame: August 2010 - December 2011
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 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 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 Infant, Very Low Birth Weight, 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 4 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 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?
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?
To evaluate the current standard of care of nutritional management (time frame: August 2010 - December 2011). 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; AzTrials last refreshed its copy on 7 Nov 2026.