Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU

Completed

Conditions studied: Infant, Very Low Birth Weight

In brief

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.

Key facts

Study ID

NCT01204983

Run by

Baylor College of Medicine

People needed

150

Starts

2010-07-01

Expected to finish

2025-12-31

Last updated by the study team

2026-01-29

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Premature infants (<37 weeks gestation) with a birth weight less than or equal to 1250 grams.

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine / Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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