Melatonin for Pulmonary Hypertension in Full Term Neonates

NCT06685679 | Completed Phase 3

• 1 other identifier: Melatonin in pulmonary hyperte
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Published evidence has provided a possible role of melatonin and the treatment of pulmonary hypertension through its strong antioxidant properties and improving vascular function in animals. This study will test the hypothesis of the possible use of melatonin as an adjunct therapy to milrinone for neonatal pulmonary hypertension.

Conditions

Neonatal Diseases and Abnormalities; Neonatal Mortality; Pulmonary Arterial Hypertension; Pulmonary Arterial Hypertension, Children

Keywords

Neonate; Pulmonary hypertension; Melatonin; Milrinon

Outcome Measures

Primary Outcomes (2)

• Pulmonary arterial pressure

  Measuring pulmonary artery pressure by echocardiography

  After 72 hours of the start of the drug

• FiO2

  FiO2 needs to maintain oxygen saturation monitored non invasively

  Hourly for 3 days

Secondary Outcomes (1)

• Hospital stay

  One month

Study Arms (2)

Intervention group melatonin group

EXPERIMENTAL

Intervention group : will receive oral melatonin (Kids Daily Vit Sleep syrup) 3 mg/kg/day divided in 3 doses , after enteral feeding, for 3 consecutive days, as combined therapy to milrinone (Garofoli et al., 2021). Human studies documented that short-term use of melatonin is safe, even in extreme doses (Andersen et al., 2016).

Drug: Melatonin

Control group

PLACEBO COMPARATOR

Control group: will receive the treatment of PHN as our NICU protocol in the form of loading dose of milrinone (50 μg/kg) over 60 mins followed by a maintenance infusion (0.33-0.99 μg/kg/min) for 72 hrs. (McNamara et al., 2013) And equivalent amout of distilled water as a placebogive at same time intervals as melatoni

Other: Placebo

Interventions

Melatonin DRUG

oral melatonin 3 mg/kg/day divided in 3 doses , after enteral feeding, for 3 consecutive days, as combined therapy to milrinone

Intervention group melatonin group

Placebo OTHER

Equivalent amount of distilled water will be given every hours as combined therapy to milrinone

Control group

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• full term neonates ≥37 weeks diagnosed with pulmonary hypertension, with Pulmonary arterial pressure (PAP) \> 25 mm Hg measured by echocardiography, within 72 h of birth (Chetan et al., 2022).

You may not qualify if:

• Neonates with major congenital anomalies like congenital heart diseases
• NPO or any contraindications to oral intake
• Neonates with suspected inborn error of metabolism

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

Related Publications (2)

• Chetan C, Suryawanshi P, Patnaik S, Soni NB, Rath C, Pareek P, Gupta B, Garegrat R, Verma A, Singh Y. Oral versus intravenous sildenafil for pulmonary hypertension in neonates: a randomized trial. BMC Pediatr. 2022 May 27;22(1):311. doi: 10.1186/s12887-022-03366-3.

  PMID: 35624452 BACKGROUND

• 1- Andersen LPH., Gögenur I, Rosenberg J, Reiter RJ. The safety of melatonin in humans. Clin Drug Investig. 2016 Mar. 36(3), 169-175. 2- Ballard JL, Khoury JC, Wedig K, Wang L, Eilers-Walsman BL and Lipp R. New Ballard Score, expanded to include extremely premature infants. J pediatr. 1991 sep. 119(3), 417-423. 3- Chetan C, Suryawanshi P, Patnaik S, Soni NB, Rath C, Pareek P,et al. Oral versus intravenous sildenafil for pulmonary hypertension in neonates: a randomized trial. BMC pediatr . 2022 May . 22(1), 1-7. 4- D'Angelo, G., Chimenz, R., Reiter, R. J., & Gitto, E. Use of melatonin in oxidative stress related neonatal diseases. Antioxidants. 2020, 9(6), 477

  BACKGROUND

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of pediatrics, Ain shams university

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: May 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: March 15, 2025
• Last Updated: July 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)