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Clinical Trials/EUCTR2015-004228-70-SE
EUCTR2015-004228-70-SE
Active, not recruiting
Not Applicable

A randomized, double blind, parallel-group, dose escalation placebo-controlled multicentre study to investigate the safety and tolerability of IBP-9414 administered in preterm infants

Infant Bacterial Therapeutics AB0 sites120 target enrollmentOctober 7, 2015
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ConditionsPrevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 gramsTherapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams
Sponsor
Infant Bacterial Therapeutics AB
Enrollment
120
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 7, 2015
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Gestational age \=32 weeks (determined by fetal ultrasound in 1st trimester if available, first day of last menstrual period and best obstetric estimate).
  • •2\.Birth weight: 1,001 – 2,000 g (Cohorts A \& B); 500 – 1,000 g (Cohorts C \& D).
  • •3\.\< 48 hours of age.
  • •4\.Written informed consent from the patient’s legally authorized representative(s).
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 120
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\. Participation in an additional interventional clinical trial in which an investigational drug will be administered.
  • •2\. Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
  • •3\. Congenital or acquired gastrointestinal pathology.
  • •4\. Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.

Outcomes

Primary Outcomes

Not specified

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