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:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01236833
Eligibility Criteria:
Inclusion Criteria:
* Birth gestational age (GA) between 25 and 32 weeks
* Corrected gestational age less than 34 weeks
* Enteral feeding tolerated at a minimum of 10 ml/kg/day for a minimum of 48 hours
* Severe feeding intolerance, defined as a minimum of one or more of the following signs leading to withholding of milk feedings on two evaluations over 12 to 24 hours:
1. Significant increased abdominal girth, as evaluated by the treatment team, with abdominal tenderness
2. Visible enlarged bowel loops with abdominal tenderness
3. Recurrent emesis leading to withhold feeds
4. Gastric residuals in excess of one feeding, recurrent or with growing abdominal girth
5. Visible blood in stools without anal etiology
* Documented informed consent for participation in the study
Exclusion Criteria:
* Infants who already reached full enteral feeds for 72 hours, in fact a minimum of 130 ml/kg/day enteral feeds without parenteral supplementation.
* Small for gestational age (SGA) (weight at or less than the 3rd percentile on the Fenton growth chart)
* NEC (Bell's stage II or higher, radiologic evidence of NEC, pneumatosis intestinalis or free intraperitoneal air)or history of NEC
* Gastric or intestinal occlusion (no transit, absent bowel sounds, incessant vomiting, bile stained vomiting or air fluid levels)
* Major congenital malformation
* Septic infants requiring therapeutic antibiotics or antimycotics (infants only on prophylactic antibiotics or antimycotics should not be excluded).
* Patients judged as being too ill to enroll in this study, as defined by a requirement for mechanical ventilation with \>50% FIO2
* Patent Ductus Arteriosus requiring ibuprofen, indomethacin or ligature, until one week after the end of treatment
* Intraventricular Haemorrhage grade 3 or 4
* Hypernatremia ≥ 150 mmol/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Days
Study:
NCT01236833
Study Brief:
Protocol Section:
NCT01236833