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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01722760
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : November 6, 2015
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Birgitte Johanne Schmidt, Hillerod Hospital, Denmark

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.

Condition or disease Intervention/treatment
Term Delivery With Preterm Labor, Third Trimester Term Delivery With Preterm Labor, Unspecified Trimester Bronchopulmonary Dysplasia Procedure: measurements

Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD
Study Start Date : August 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin A

Group/Cohort Intervention/treatment
Term and preterm infants
Term and preterm infants
Procedure: measurements

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.

Biospecimen Retention:   Samples Without DNA
Air samples for Nitrogen oxide NO. Maternal, cord and neonatal blood samples for vitamins A and D.

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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Term and preterm infants admitted to Neonatal Care Unit for reference material as control group.

Preterm infants admitted to Neonatal Intensive Care Unit developing BPD as study group.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01722760

Neonatal departement GN, Rigshospitalet
Copenhagen, Region H, Denmark, 2200
Children´s Departement, North Zealand Hospital, Hilleroed
Hilleroed, Region H, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Rigshospitalet, Denmark
Principal Investigator: Birgitte J Schmidt, MD Children´s Dep, North Zealand Hospital Hilleroed, Denmark

Responsible Party: Birgitte Johanne Schmidt, MD, Hillerod Hospital, Denmark Identifier: NCT01722760     History of Changes
Other Study ID Numbers: H-4-2012-091
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015

Keywords provided by Birgitte Johanne Schmidt, Hillerod Hospital, Denmark:
Bronchopulmonary Dysplasia
Nasal Continuous Positive airway Pressure (CPAP)
Vitamin A
Vitamin D
Nitrogen oxide (NO)
Reference material

Additional relevant MeSH terms:
Premature Birth
Bronchopulmonary Dysplasia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Vitamin A
Vitamin D
Retinol palmitate
Nitric Oxide
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Bone Density Conservation Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents