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

Brief Title

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

Official Title

AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD

Brief 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.
    

Study Type

Observational

Primary Outcome

Tidal exhaled Nitrogen Oxide

Secondary Outcome

 Vitamin levels

Condition

Term Delivery With Preterm Labor, Third Trimester

Intervention

measurements

Study Arms / Comparison Groups

 Term and preterm infants

Description:  Term and preterm infants

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

1500

Start Date

August 2013

Completion Date

November 2015

Primary Completion Date

November 2015

Eligibility Criteria

        Inclusion Criteria:

        Cohort inclusion - All term and preterm infants admitted to Neonatal (Intensive) Care Unit.
        Gestational Age 24-42 weeks.

        Exclusion Criteria:

          1. Children with ciliary dyskinesia, as NO is distinguishable lower in these children.

          2. Children who can not cooperate to the examination.

          3. Children so dependant on oxygen, that the examination/measurement is not possible.

          4. Children with pneumothorax

          5. Children having a diagnosed pneumonia verified by tracheal secrete.

          6. Children with bigger congenital anomalies
      

Gender

All

Ages

N/A - 2 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Birgitte J Schmidt, MD, , 

Location Countries

Denmark

Location Countries

Denmark

NCT ID

NCT01722760

Organization ID

H-4-2012-091

Responsible Party

Principal Investigator

Study Sponsor

Hillerod Hospital, Denmark

Collaborators

 Rigshospitalet, Denmark

Study Sponsor

Birgitte J Schmidt, MD, Principal Investigator, Children´s Dep, North Zealand Hospital Hilleroed, Denmark

Verification Date

November 2015