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NCT Number: NCT01722760

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children with ciliary dyskinesia, as NO is distinguishable lower in these children.
  • Children who can not cooperate to the examination.
  • Children so dependant on oxygen, that the examination/measurement is not possible.
  • Children with pneumothorax
  • Children having a diagnosed pneumonia verified by tracheal secrete.
  • Children with bigger congenital anomalies

Treatment and study plan

measurements

Procedure

Primary outcomes

  1. Tidal exhaled Nitrogen Oxide

    Time frame: 6-7 measures within the first 2 months of life and at 1 year of age.

    Reference material of tidal expiratory NO in a cohort of neonates admitted to Neonatal Intensive Care Unit and Neonatal Care Unit will be made.

    All children in the study will be measured on 8 occasions including a one year follow up.

    Association with Bronchopulmonary Dysplasia (BPD) and the measures above will be noted.

Secondary outcomes

  1. Vitamin levels

    Time frame: From birth to a one year follow up

    Blood levels of Vitamins A (s-retinol) and D (se-25(OH)D2 and D3) will be measured at 3 preset occasions and at one year follow up, as well as maternal and cord blood at the time of birth.

    Reference material will be made and association to BPD will be noted.

Other outcomes

  1. Bronchopulmonary Dysplasia

    Time frame: From premature birth to a one year follow up

    The incidence of BPD and the correlation the the above mentioned biomarkers.

Sponsors and collaborators

Lead sponsor

Hillerod Hospital, Denmark

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2012
Registry last updated
Nov 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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