Melatonin Effects on the Left Ventricular Function in Neonates With Persistent Pulmonary Hypertension

Tanta University

Status: Completed

Conditions: Left Ventricular Function; Neonates; Persistent Pulmonary Hypertension; Melatonin

Treatments: Other: Placebo; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT07090720

36173//12/22

Details and patient eligibility

About

This study aimed to evaluate the effect of melatonin on the left ventricular function in neonates with persistent pulmonary hypertension

Full description

Persistent pulmonary hypertension of the newborn (PPHN) is a potentially deadly disorder in which the circulation of the fetus is unable to adjust to the extrauterine environment. Persistently high pulmonary pressures may cause right-to-left shunting, hypoxia, and right ventricular failure.

Melatonin, a neurohormone produced by the pineal gland, offers an exceptional defense against reactive oxygen species (ROS). Infants are unable to synthesize melatonin during their first few weeks of life, which may exacerbate oxidative stress in hypoxic conditions. Additionally, Melatonin's antioxidative capabilities have been shown in neonatal pulmonary and respiratory disorders.

Enrollment: 80 patients

Sex: All

Ages: 36+ weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neonates of ≥ 36 weeks of gestational age.
• Both sexes.
• Admitted with persistent pulmonary hypertension.

Exclusion criteria

• Preterm infants < 36 weeks of gestation.
• Infants with congenital heart diseases.
• Infants with dysrhythmia.
• Chromosomal abnormalities.
• Severe pathological jaundice.
• Metabolic or endocrinal disorders.
• Major congenital malformations.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups, including a placebo group

Group I

Experimental group

Description:

Neonates were given Melatonin.

Treatment:

Drug: Melatonin

Group II

Placebo Comparator group

Description:

Neonates received placebo.

Treatment:

Other: Placebo