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milrinone in persistent neonatal pulmonary hypertension

Comparing the efficacy of inhaled versus infused milrinone in management of persistent pulmonary hypertension(PPHN) in infants

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220130053890N1
Enrollment
32
Registered
2022-02-26
Start date
2022-03-01
Completion date
Unknown
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neonatal.

Interventions

Intervention 1: Intervention group: treated with intravenous infusion of dopamine at a dose of 5 macro per kg body weight per minute for 3 to 5 days according to the doctor and then receive inhaled mi

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Infants 1 to 28 days with a diagnosis of persistent pulmonary hypertension (diagnosed on Basis of echocardiographic findings) and hospitalization in the NICU. Indicated for receiving treatment based on the diagnosis of the treating physician. Existence of informed consent of parents to enter the study.

Exclusion criteria

Exclusion criteria: Neonates with congenital heart disorders, diaphragmatic hernias, pulmonary abnormalities. infants are candidates for major surgery to eliminate abnormality.

Design outcomes

Primary

MeasureTime frame
Pulmonary artery pressure: pulmonary artery pressure greater than 40 mm Hg is considered PPHN. Timepoint: it is measured at first, during the first 24 hours of hospitalization, 24 hours after the start of treatment, and when the infant shows signs of respiratory distress or increased oxygen demand. Method of measurement: Pulmonary artery pressure is determined by M-mode, two-dimensional, and color-Doppler echocardiography using the Bernoulli formula. Bernoulli equation: pulmonary artery systolic pressure (PASP) = tricuspid regurgitation gradient + right atrial pressure (RAP), PASP = (Vmax2 × 4) + RAP.;Systemic artery pressure: Systolic and diastolic blood pressure. Timepoint: daily. Method of measurement: Using the NICU monitoring device.;Signs of respiratory distress: Respiratory distress in the newborn is recognized as one or more signs of increased work of breathing, such as tachypnea, nasal flaring, chest retractions, or grunting. Timepoint: The baby is constantly monitored. Method of measurement: Through clinical examination of the patient.;Oxygenation index(OI) : is used to assess the severity of hypoxic respiratory failure (HRF) and persistent pulmonary hypertension of the newborn (PPHN). Timepoint: Daily and at the time of respiratory distress. Method of measurement: It is calculated by the following formula: (OI=mean airway pressure MAP × FiO2 × 100÷PaO2).

Secondary

MeasureTime frame
Die or survive. Timepoint: During treatment. Method of measurement: See the patient.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactpeyman shahhosseini

Iran University of Medical Sciences

peishah@yahoo.com+98 21 8801 6197

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026