NCT04004091

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: dr. Riana Pauline Tamba, SpB(K)BA · Academic / Other
• Sex: All
• Age: 24 Days – 28 Days
• Healthy volunteers: Accepted

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.

Detailed description

This experimental study is conducted with minimum 24 subjects which divided into 6 groups; 1) 24-days pregnant and is given prenatal spermine, 2) 26-days pregnant and is given prenatal spermine, 3) 28-days pregnant and is given prenatal spermine, 4) 24-days pregnant and is not given prenatal spermine, 5) 26-days pregnant and is not given prenatal spermine, and 6) 28-days pregnant and is not given prenatal spermine. At the end of desired pregnancy period, hysterectomy is done and fetus are born. From each parent subject, three fetal samples are chosen using a random sampling. Intestinal tissues are taken from each fetal sample to be examined. Several data will be collected i.e. occludin, β-catenin, and β-actin, as well as histological morphologies.

Conditions

• Premature Birth
• NEC

Interventions

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

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2019-07-01
• Last updated: 2020-03-17

Locations

1 site across 1 country: Indonesia

Regulatory

• FDA-regulated drug study