Gastrointestinal Maturation in Preterm Infants.
Conditions
Interventions
Product Code: NTRA-2112
Pharmaceutical Form: Oral powder in sachet
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Current Sponsor code: NTRA-2112
Concentration unit: IU international unit(s
Sponsors
Nutrinia Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female pre-term infants 26-32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and early antenatal ultrasound (no intra-uterine retardation). 2. Birth weight ? 500 gr. 3. Postnatal age up to 5 days. 4. Fraction of inspired oxygen ? 0.60 at enrollment. 5. The infant is in a cardiovascular stable condition. 6. No heart and chest compression or any resuscitation drugs given to the infant during delivery. 7. Informed consent form signed by parents or legal guardian. 8. In the Investigator?s opinion, is able to comply with the trial requirements. Are the trial subjects under 18? yes Number of subjects for this age range: 250 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Pre-term infants age > 32 weeks or 5 days 4. Fraction of inspired oxygen > 0.60 at enrollment. 5. The infant is in cardiovascular instability. 6. Complete enteral feeding. 7. Major congenital malformation ? Infants with genetic metabolic or endocrine disorder diagnosed before enrollment (including disorders diagnosed after enrollment but are known to be congenital). 8. High index of suspicion of infection before enrollment. 9. Confirmed NEC. 10. Maternal diabetes. 11. The infant is treated with Insulin. 12. NPO, nothing per os for any reason at the study entry. 13. Heart and chest compression or any resuscitation drugs given to the infant during delivery. 14. Participation in another clinical study. 15. In the Investigator?s opinion, is not able to comply with the trial requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of NTRA-2112 on gastrointestinal maturation by the time required to reach full enteral feeding in preterm infants during the treatment period as compared to a Placebo formulation.;Secondary Objective: -To assess the effect of NTRA-2112 on number of days to achieve readiness to discharge (based on predefined criteria) from the hospital as compared to Placebo formulation. -To assess the effect of NTRA-2112 on the number of days to end gastric residuals over 3 ml during the treatment period as compared to Placebo formulation. -To assess the effect of NTRA-2112 on growth by assessing: the weight gain ,body length and head circumference in the preterm infants as compared to Placebo formulation - To assess the safety of NTRA-2112 for preterm infants as compared to Placebo formulation;Primary end point(s): Numbers of days to achieve complete enteral feeding (NFE) defined by: Number of Days to achieve enteral feeding of 150 cc/kg/day for at least 3 consecutive days Note that the NFE will be computed until the first of the three consecutive days.;Timepoint(s) of evaluation of this end point: Up to 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of Day to Readiness-for-Discharge (NRD), defined by meeting all the criteria enumerated below: 1. Infant weight ? 1800 g 2. Stable body temperature Readiness for oral feeding;Timepoint(s) of evaluation of this end point: Up to 3 months | — |
Countries
Belgium, Bulgaria, Germany, Hungary, Netherlands, Spain
Contacts
Public ContactPunto de Información
SAIL SLL
Outcome results
None listed