CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 42 enrolled
Drug / intervention
Sperminebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04004091
NCT04004091Early Ph 1Completed
CompareCT.gov

Prenatal Administration of Oral Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Oryctolagus Cuniculus

dr. Riana Pauline Tamba, SpB(K)BA·interventional·Posted Jul 1, 2019·Updated Mar 17, 2020

In Brief

A Early Phase 1 clinical trial evaluating Spermine for Premature Birth and NEC. Completed, enrolled 42 participants across 1 site.

Detailed Summary

Infections, particularly on the gastrointestinal tract, has been known to be one of the leading causes of death in preterm infants. This is due to the immaturity of the intestinal epithelial cells. Recent studies have shown that polyamines have a role on the development of cells during embryonal phase. By this experimental study, the investigators would like to evaluate the administration of spermine on the maturation of premature fetal gut epithelial tight junction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Birth, NEC
CountriesIndonesia
Collaborators--

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedJul 1, 2019
Enrollment StartMar 1, 2019
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.0 years ago

Interventions

Sperminebiological

Spermine is a polyamine. It is an organic molecule that is involved in cellular metabolism and development.