Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/5/2019 |
| Start Date: | July 2010 |
| End Date: | August 2019 |
| Contact: | Amy B Hair |
| Email: | abhair@texaschildrens.org |
| Phone: | 7138767323 |
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices With Donor Human Milk Products in the NICU
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.
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.
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.
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.
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
We found this trial at
1
site
Houston, Texas
Principal Investigator: Amy Hair, MD
Phone: 832-826-3719
Click here to add this to my saved trials
