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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01204983
First received: September 16, 2010
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition
Infant, Very Low Birth Weight

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices With Donor Human Milk Products in the NICU

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • To evaluate the current standard of care of nutritional management [ Time Frame: August 2010 - December 2011 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To ensure that guidelines for VLBW infants are followed [ Time Frame: August 2010 - December 2011 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Premature, very low birth weight infants only

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204983

Contacts
Contact: Keli Hawthorne 713-798-7085 kelih@bcm.edu

Locations
United States, Texas
Baylor College of Medicine / Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Keli M Hawthorne, MS, RD    713-798-7085    kelih@bcm.edu   
Principal Investigator: Steve Abrams, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Steven A Abrams, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Steve Abrams, MD, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01204983     History of Changes
Other Study ID Numbers: H-26923
Study First Received: September 16, 2010
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
very low birth weight infant
donor human milk

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014