Inhaled nitric oxide in preterm infants: a systematic review and individual patient data meta-analysis

A systematic review of preterm infants inhalation of nitric oxide vs placebo for reduction in infant mortality and morbidity

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000859280

Acronym

MAPPINO

Enrollment

3567

Registered

2009-10-02

Start date

2006-12-18

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Several randomized controlled trials have been conducted in preterm infants to determine whether inhaled nitric oxide (iNO) reduces the rates of death and/or chronic lung disease. The results of these studies appear contradictory. Some studies have shown a reduction in lung injury, one has shown a reduction in cerebral injury, and several others have shown no effect. The different patient characteristics and different trial characteristics within these trials may explain this difference. The purpose of this systematic review and individual patient data meta-analysis is to determine whether inhaled nitric oxide in preterm infants receiving assisted ventilation improves survival without morbidity, specifically without chronic lung disease (CLD), cerebral injury, retinal injury, and improves survival without long-term disability. Secondly to determine whether the effects of inhaled nitric oxide differ according to the risk profile of the patient in terms of gestational age at birth, severity of illness, antenatal steroid use, postnatal age at the time of randomization, ventilation mode at randomization, administration of exogenous surfactant, inhaled nitric dosage and duration of nitric oxide administration.

Interventions

Inhaled Nitric Oxide (iNO) relaxes vascular smooth muscle by activating guanyl cyclase and leading to the production of cyclic GMP (guanosine monophosphate). Infants received multiple randomized doses of iNO from 5 to 80 ppm until weaned if effective. Maximum treatment days ranged from 3 days to 24 days. Frequencies and duration of doses varied between the 11 trials.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

24 Weeks to 37 Weeks

Healthy volunteers

Inclusion criteria

For the purposes of this meta-analysis it was decided to include any trials that were: Studies will be included if they are randomised controlled trials preterm infants (<37 weeks) receiving assisted ventilation

Exclusion criteria

For the purposes of this meta-analysis it was decided to exclude any trials that were: Non randomised controlled trials using term infants

Outcome results