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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 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.

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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.

Study Locations (1)

Texas

  • Baylor College of Medicine / Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2010-07-01
Est. Completion 2025-12-31

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT01204983

The ClinicalTrials.gov registry entry for NCT01204983 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 270-participant average among 4 other Infant, Very Low Birth Weight trials with a reported enrollment target (44% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Infant, Very Low Birth Weight appearing as the primary indexed condition, and to 0 interventions.

NCT01204983 reports 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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