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

Maternite Regionale Universitaire

Status and phase: Completed; Phase 4

Conditions: Premature Birth

Treatments: Drug: Nitric Oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT00390065

MRAP060308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Parental refusal

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 3 patient groups, including a placebo group

Study group

Experimental group

Description:

Hypoxemic Respiratory Failure treated by Nitric Oxide;

Treatment:

Drug: Nitric Oxide

Control

Placebo Comparator group

Description:

Hypoxemic Respiratory Failure control (Placebo);

Treatment:

Drug: Nitric Oxide

Reference

No Intervention group

Description:

Reference (Non hypoxemic respiratory failure)