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NCT01204983 · ClinicalTrials.gov registry record
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU
A clinical trial of Infant, Very Low Birth Weight, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT01204983: Completed study of Infant, Very Low Birth Weight, sponsored by Baylor College of Medicine.
NCT01204983 is a study of Infant, Very Low Birth Weight that has completed, run by Baylor College of Medicine. The registered enrollment target is 150 participants, below the 270-participant average among 4 other Infant, Very Low Birth Weight trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01204983, a study of Infant, Very Low Birth Weight, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
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 |
What the finished NCT01204983 record still lists
NCT01204983 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 270-participant average among 4 other Infant, Very Low Birth Weight trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Infant, Very Low Birth Weight appearing as the primary indexed condition, and to 0 interventions.
NCT01204983 reports a single indexed study location in Texas.
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.
Who is sponsoring clinical trial NCT01204983?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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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