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Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU
NCT01204983 · View on ClinicalTrials.gov ↗
Study 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. 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.
Conditions Studied
Study Locations (1)
Texas
- Baylor College of Medicine / Texas Children's Hospital — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2010-07-01 |
| Est. Completion | 2025-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01204983
The ClinicalTrials.gov registry entry for NCT01204983 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 678 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Infant, Very Low Birth Weight appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01204983 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01204983 about?
NCT01204983 is a clinical study titled "Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices 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 th...
What is the current status of trial NCT01204983?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2010-07-01. Estimated completion is 2025-12-31.
What conditions does trial NCT01204983 study?
This clinical trial studies the following conditions: Infant, Very Low Birth Weight. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01204983?
This trial is sponsored by Baylor College of Medicine, which has 678 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01204983 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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