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

NCT ID: NCT01204983

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2025-12-31

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.

Detailed Description

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.

Infants will be identified by the dietitian staff at TCH upon admission to the NICU (Levels 2 and 3) and communicated to the PI and PI's staff.

For each subject, data collection will begin at the point that the infant first receives any enteral feeding (including trophic feeds). All infants less than or equal to 1250 g birth weight will be followed initially. If the parent declines to allow donor human milk products for the infant, this will be noted in the data collection and no additional data will be collected for this infant. If at a later time, the parent decides to allow donor human milk products, we will begin data collection again. Our current experience is that >95% of mothers agree to donor human milk products.

Data collection will continue throughout the hospitalization until one week after all donor human milk products have been discontinued or discharge.

From the medical chart, we will record the following data on a weekly basis: weight, length, head circumference, labs (Chem 10 panel - BUN, creatinine, sodium, potassium, bicarbonate, chloride, calcium, phosphorus, magnesium, and glucose), medications, and the nutrition order (parenteral and enteral nutrition feeding orders including volume, concentration, and additives). If an abnormal nutrition-related lab is noted, changes in the nutrition order will be recorded more frequently than on a weekly basis. A copy of the data collection template is attached in Section S.

No labs will be requested for research purposes. No interventions are part of this protocol. This protocol involves only minimal risk to individuals. A waiver of consent would not in any way adversely affect the privacy rights and the welfare of the individuals.

Conditions

Infant, Very Low Birth Weight

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Amy Hair

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Hair, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy B Hair

Role: CONTACT

abhair@texaschildrens.org

7138767323

Facility Contacts

Amy B Hair, MD

Role: primary

abhair@texaschildrens.org

832-826-3719

Other Identifiers

H-26923

Identifier Type: -

Identifier Source: org_study_id