Neonatal ventilation with INhaled Nitric Oxide versus Ventilatory support withOut inhaled nitric oxide for severe respiratory failure: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17821339

Enrollment

160

Registered

2000-10-25

Start date

1997-02-01

Completion date

Unknown

Last updated

2022-09-12

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

Conditions

Respiratory disease Neonatal Diseases Respiratory failure

Interventions

Nitric oxide/control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Respiratory failure requiring ventilatory support 2. Less than 28 days old 3. No evidence of uncorrected bleeding disorder 4. No ultrasound evidence of intraparenchymal lesions 5. No contra-indication to continuation of treatment, known at trial entry 6. Informed assent of the parent(s) following discussion and written information

Exclusion criteria

Exclusion criteria: Does not comply with above criteria

Design outcomes

Primary

Measure	Time frame
1. To conduct relevant sub-studies 2. Death 3. Severe disability at 1 year of age (corrected) 4. Chronic lung disease, defined as being on supplemental oxygen at the expected date of delivery (preterm stratum) and at 28 days post delivery ('mature stratum') 5. Length of time on supplemental oxygen 6. Costs	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

England, Ireland, United Kingdom

Outcome results

None listed

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