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

dr. Riana Pauline Tamba, SpB(K)BA

Status and phase: Completed; Early Phase 1

Conditions: NEC; Premature Birth

Treatments: Biological: Spermine

Study type: Interventional

Funder types: Other

Identifiers

NCT04004091

tight junction, spermine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 24 to 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Intestinal tissue of fetal rabbit that is prematurely alive

Exclusion criteria

• Intestinal tissue of fetal rabbit that is dead before termination
• Intestinal tissue of fetal rabbit, in which the parent died before termination

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 6 patient groups

24-Day Spermine Group

Experimental group

Description:

Subjects are given prenatal spermine (20 mg per body weight) during 24 days of pregnancy. On day 24 pregnancy is terminated and intestinal tissue sample is taken to be examined.

Treatment:

Biological: Spermine

26-Day Spermine Group

Experimental group

Description:

Subjects are given prenatal spermine (20 mg per body weight) during 26 days of pregnancy. On day 26 pregnancy is terminated and intestinal tissue sample is taken to be examined.

Treatment:

Biological: Spermine

28-Day Spermine Group

Experimental group

Description:

Subjects are given prenatal spermine (20 mg per body weight) during 28 days of pregnancy. On day 28 pregnancy is terminated and intestinal tissue sample is taken to be examined.

Treatment:

Biological: Spermine

24-Day Non Spermine Group

No Intervention group

Description:

Subjects are not given any intervention. On day 24 pregnancy is terminated and intestinal tissue sample is taken to be examined.

26-Day Non Spermine Group

No Intervention group

Description:

Subjects are not given any intervention. On day 26 pregnancy is terminated and intestinal tissue sample is taken to be examined.

28-Day Non Spermine Group

No Intervention group

Description:

Subjects are not given any intervention. On day 28 pregnancy is terminated and intestinal tissue sample is taken to be examined.