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Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study

NCT01722760 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2015-11-06

No results posted yet for this study

Summary

Children born prematurely are of greater risk of developing chronic lung disease (Bronchopulmonary Dysplasia).

With an increase in the amount of premature children, we expect an increasing number of children with BPD.

Today we do not have many ways of predicting or treating this condition, and the children are usually in hospital for several months after birth. Many are dismissed with home oxygen. Children with BPD are typically often re-submitted to hospital with respiratory disease the first couple of years, and some of them have problems throughout childhood and into adulthood.

Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary Disease (COPD).

The condition as well as the treatment (steroids), are associated with great risk of adverse effects as Cerebral Palsy, blindness, deafness and mental retardation.

The investigators wish to find a safe way to identify the children in greater risk of developing BPD, who could therefore benefit from a more intensive treatment.An early diagnosis would increase the possibility of predicting the prognosis.

Other studies have proven a connection between both low vitamin A and D and high exhaled nitrogen oxide (NO) with lung disease.

With this trial the investigators wish to make a reference material for NO and vitamins A and D in infants admitted to the neonatal department at two hospitals in Denmark, both with and without treatment with nasal Continuous Positive Airway Pressure.

The investigators furthermore wish to describe an eventual connection between BPD and these factors by examining a large group of children on 7 specific occasions within the first two months of life and at a one year follow up.

Conditions

  • Term Delivery With Preterm Labor, Third Trimester
  • Term Delivery With Preterm Labor, Unspecified Trimester
  • Bronchopulmonary Dysplasia

Interventions

PROCEDURE

measurements

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Hillerod Hospital, Denmark

    lead OTHER

Principal Investigators

  • Birgitte J Schmidt, MD · Children´s Dep, North Zealand Hospital Hilleroed, Denmark

Eligibility

Max Age
2 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01722760 on ClinicalTrials.gov