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

Infant, Very Low Birth Weight Clinical Trial

— NICU  

Official title:

Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices With Donor Human Milk Products in the NICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01204983
• Other study ID #: H-26923
• Status: Recruiting
• Start date: July 2010
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: Amy B Hair
• Phone: 7138767323
• Email: abhair[@]texaschildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Infant, Very Low Birth Weight

Locations

Country	Name	City	State
United States	Baylor College of Medicine / Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To ensure that guidelines for VLBW infants are followed	To ensure that guidelines to monitor electrolytes in infants < 1250 g receiving donor human milk products are being followed and that appropriate interventions are being given if abnormalities are determined.	August 2010 - December 2011