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New treatment option for Prematurity; Extreme
Official title Targeted Fortification of Donor Breast Milk in Preterm Infants
ClinicalTrials.gov ID: NCT04294368
What this study is testing
- What it's testing
- This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 21
You may be able to join if
- Premature infants born \</= 30 weeks gestational age
- Birth Weight \</= 1500 grams
You likely can't join if
- Parents do no consent to donor milk
- Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies
- Grade III or IV intraventricular hemorrhage diagnoses prior to randomization
- Small for gestational age (\<3% on Fenton Growth Curve)
- Failure to initiate fortified feeds prior to 3 weeks of life
- Diagnosis of necrotizing entercolitis prior to randomization
See the full eligibility criteria
- Premature infants born \</= 30 weeks gestational age
- Birth Weight \</= 1500 grams
- Parents do no consent to donor milk
- Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies
- Grade III or IV intraventricular hemorrhage diagnoses prior to randomization
- Small for gestational age (\<3% on Fenton Growth Curve)
- Failure to initiate fortified feeds prior to 3 weeks of life
- Diagnosis of necrotizing entercolitis prior to randomization
- Diagnosis of early onset sepsis confirmed with positive culture
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 21 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.