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

NCT01204983 | Completed

• 1 other identifier: H-26923
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Infant, Very Low Birth Weight

Keywords

very low birth weight infant; donor human milk

Outcome Measures

Primary Outcomes (1)

• 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.

  August 2010 - December 2011

Secondary Outcomes (1)

• To ensure that guidelines for VLBW infants are followed

  August 2010 - December 2011

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Premature, very low birth weight infants only

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Study Officials

• Amy Hair, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 20, 2010
• Study Start: July 1, 2010
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)