Evaluation of early and combined treatment with surfactant and inhaled nitric oxide in newborns with respiratory failure and pulmonary hypertension

Randomized controlled trial to assess the early addition of exogenous surfactant to inhaled nitric oxide in the treatment of newborns with respiratory failure and pulmonary hypertension

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13727958

Enrollment

100

Registered

2019-09-06

Start date

2009-03-01

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

Neonatal hypoxic respiratory failure and pulmonary hypertension Neonatal Diseases

Interventions

Enrolled infants were randomized into one of the two study groups using sequential sealed opaque envelopes from a computer-generated randomization list. This allocation sequence was generated centrall

Chiesi Farmaceutici, Italy) Control group: received treatment with 20 ppm iNO + placebo (air) and standard intensive care, which in both groups includes high frequency or conventional

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Near term infants (35 weeks gestation) with birth weights > 2000 g and who are less than 72 hours old 2. Infants requiring mechanical ventilation with hypoxemic respiratory failure with an OI > 20, calculated on two consecutive measurements of post ductal arterial blood gases without acidosis (pH > 7.25) and efforts will be done to adjust ventilatory support to reach a PCO2 < 60 3. A previous echocardiogram will be performed to rule out a cardiac anomaly and evaluate the presence of pulmonary hypertension (a tricuspid insufficiency jet with an estimated systolic pulmonary artery pressure = 2/3 of systemic systolic arterial blood pressure and/or evidence of right-to-left shunting through foramen ovale or ductus arteriosus)

Exclusion criteria

Exclusion criteria: 1. Life-threatening congenital anomalies 2. Congenital heart disease 3. Congenital diaphragmatic hernia 4. Other forms of lung hypoplasia syndromes 5. Suspected or confirmed chromosomal abnormality 6. Postnatal age > 72 hours

Design outcomes

Primary

Measure	Time frame
The proportion of infants developing treatment failure during the first 48 hours of study treatment, defined as an oxygenation index (OI) = 40	—

Secondary

Measure	Time frame
1. Proportion of infants requiring ECMO or death recorded during hospital stay 2. Oxygen and ventilatory requirements recorded during hospital stay	—

Countries

Chile

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026