- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204983
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU (NICU)
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices With Donor Human Milk Products in the NICU
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amy B Hair
- Phone Number: 7138767323
- Email: abhair@texaschildrens.org
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine / Texas Children's Hospital
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Contact:
- Amy B Hair, MD
- Phone Number: 832-826-3719
- Email: abhair@texaschildrens.org
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Principal Investigator:
- Amy Hair, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the current standard of care of nutritional management
Time Frame: August 2010 - December 2011
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To ensure that guidelines for VLBW infants are followed
Time Frame: August 2010 - December 2011
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amy Hair, MD, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-26923
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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