NCT07850934

Brief Summary

The aim of the study

  1. 1.To evaluate safety and efficacy of melatonin as an adjuvant therapy to inhaled nitric oxide generated by NO generator in the treatment of pulmonary hypertension in full term neonates.
  2. 2.To assess the effect of inhaled nitric oxide and melatonin on cerebral perfusion.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Jul 2025Dec 2026

Study Start

First participant enrolled

July 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 30, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 9, 2026

Last Update Submit

September 28, 2026

Conditions

Congenital PeumoniaPersistent Pulmonary Hypertension of NewbornCongenital Diaphragmatic Hernia

Keywords

Nitric oxide generatorMelatonin

Outcome Measures

Primary Outcomes (1)

  • melatonin as an adjuvant therapy to iNO

    1. oxygen saturation % every 3hrs 2. Fraction of inspired oxygen (FiO2) % which will all be measured at baseline (just before iNO administration) and at pre-specified intervals (15, 30, 45, and 60 min) after iNO then every 3hours through the course of study.

    72 hours

Secondary Outcomes (1)

  • effect of iNO and melatonin on cerebral perfusion.

    24 hours

Other Outcomes (2)

  • Effect of iNO and Melatonin on cerebral perfusion

    72 hours

  • Effect of iNO and Melatonin on electroencephalogram

    72 hours

Study Arms (2)

control

ACTIVE COMPARATOR

Control group (26Neonates) gestational age and weight matched to the intervention group and will receive only iNO will be initiated at 20 ppm without melatonin The expected clinical response will be improved oxygenation and cardio-respiratory stability in the first 30 minutes after initiation of iNO therapy. If there is no clinical response, the iNO dose will be increased to up to 40 ppm. If after 30 minutes there is no clinical response, iNO will be discontinued

Device: nitric oxide generator

Melatonin

ACTIVE COMPARATOR

Intervention group (26Neonates) will receive iNO and melatonin. melatonin will be given by nasogastric tube at a dose (3 mg/kg) divided every 8 hours till the end of iNO therapy

Drug: MelatoninDevice: nitric oxide generator

Interventions

MelatoninDRUG

Melatonin will be given by nasogastric tube at a dose (3 mg/kg) divided every 8 hours till the end of iNO therapy

Melatonin
nitric oxide generatorDEVICE

iNO will be initiated at 20 ppm. The expected clinical response will be improved oxygenation and cardio-respiratory stability in the first 30 minutes after initiation of iNO therapy.If there is no clinical response, the iNO dose will be increased to up to 40 ppm. If after 30 minutes there is no clinical response, iNO will be discontinued

Melatonincontrol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Term neonates with gestational age ≥ 37 weeks.
  • Mean Pulmonary artery pressure greater than 25mmHg with clinical manifestations as tachypnea, tachycardia, hypoxemia and hypotension

You may not qualify if:

  • Congenital methemoglobinemia.
  • Major congenital cardiac anomalies especially duct dependent systemic circulation.
  • Bleeding tendency.
  • Patients on other pulmonary vasodilators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 00202, Egypt

RECRUITING

MeSH Terms

Conditions

Persistent Fetal Circulation SyndromeHernias, Diaphragmatic, Congenital

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCongenital AbnormalitiesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2026

First Posted

September 30, 2026

Study Start

July 1, 2025

Primary Completion

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 30, 2026

Record last verified: 2026-08

Locations

EG(1)