Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT03708068
Eligibility Criteria:
Inclusion Criteria:
1. Preterm infants born at 30 0/7 - 33 6/7 weeks gestation
2. Birth weight greater than 1000 g
3. Consent to use donor human milk
4. Postnatal age is less than 48 hours from birth
5. Infant is ready to start on feeding (as per clinical team) or feeding volume, when already started, is ≤12 ml/kg per day (total) and/or the infant received ≤2 feeds based on current feeding policy or physician descrition (total volume of the received feeds is ≤20 ml/kg per day).
Exclusion Criteria:
1. Cord PH \< 7.00 or Cord base access (BE) \< -16
2. Apgar score \< 7 at 5 minute
3. Lactate level ≥3 (if done for clinical indication)
4. Need for positive pressure ventilation (PPV) for \>1 minute.
5. Hemodynamic instability (hypotension or poor perfusion at any time in this 48 hours)
6. Small for gestational age \<3 percentile on Fenton chart and/or fetal absent or reversed umbilical arterial end-diastolic blood flow.
7. Major congenital malformation
8. Symptomatic or severe hypoglycemia (blood glucose \<1.8 mmol/L)
9. Infants with moderate to severe respiratory distress.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
48 Hours
Study:
NCT03708068
Study Brief:
Protocol Section:
NCT03708068