Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely

Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely With Respiratory and Neurodevelopmental Impact of Early Treatment With Inhaled Nitric Oxide

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00390065

Enrollment

108

Registered

2006-10-19

Start date

2006-10-31

Completion date

2009-06-30

Last updated

2017-03-22

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

Conditions

Premature Birth

Keywords

Follow-up, Premature infants, Nitric Oxide, Respiratory function testing, Neurodevelopmental outcomes

Brief summary

Utilization of nitric oxide (NO) therapy has been related to a trend towards short term improvement in very premature infants. A two year follow-up of children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. This study aims to evaluate follow-up at 6 years, in respiratory and neurodevelopmental outcome, of children born very prematurely, some of them having been treated with nitric oxide in the neonatal period.

Detailed description

Utilization of nitric oxide therapy in the neonatal period has been related to a trend towards short term improvements in respiratory and neurological outcome at 28 days postnatal age or 36 weeks postconceptional age. A two year follow-up in children treated soon after birth with NO in the neonatal period, suggests that a significant improvement in neurodevelopmental outcome might occur. No long term evaluation on respiratory outcome has yet been done. This study aims to evaluate respiratory and neurodevelopmental outcome at 6 years of age in children born very prematurely, some of them having had Nitric Oxide as a rescue treatment for respiratory distress syndrome.

Interventions

DRUGNitric Oxide

Early low dose (5ppm) NO inhalation Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Randomization in the neonatal period. Blinding maintained at the time of the follow-up study

Intervention model description

This is a follow-up study, at 6 years of age, of infants randomized in the neonatal period with one other group studied as a reference group (ie 3 groups)

Eligibility

Sex/Gender

ALL

Age

6 Years to 8 Years

Healthy volunteers

Inclusion criteria

* All infants included at birth in a randomized controlled trial using early nitric oxide therapy

Exclusion criteria

* Parental refusal

Design outcomes

Primary

Measure	Time frame
Pulmonary Function testing	at 7 years postnatal age

Secondary

Measure	Time frame
Neurodevelopmental and Cognitive outcomes	at 7 years of age

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026