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

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

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 Overview

• Status: Completed
• Conditions: Bronchopulmonary Dysplasia; Term Delivery With Preterm Labor, Third Trimester; Term Delivery With Preterm Labor, Unspecified Trimester
• Intervention / Treatment: Procedure: measurements

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• Denmark
  • Region H
    • Copenhagen, Region H, Denmark, 2200
      • Neonatal departement GN, Rigshospitalet
    • Hilleroed, Region H, Denmark, 3400
      • Children´s Departement, North Zealand Hospital, Hilleroed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal exhaled Nitrogen Oxide	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.	6-7 measures within the first 2 months of life and at 1 year of age.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin levels	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.	From birth to a one year follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bronchopulmonary Dysplasia	The incidence of BPD and the correlation the the above mentioned biomarkers.	From premature birth to a one year follow up

Collaborators and Investigators

• Sponsor: Hillerod Hospital, Denmark
• Collaborators: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Birgitte J Schmidt, MD, Children´s Dep, North Zealand Hospital Hilleroed, Denmark

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Estimate): November 6, 2015
• Last Update Submitted That Met QC Criteria: November 5, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Vitamin D; Neonatal; Oxygen; Preterm; Vitamin A; Bronchopulmonary Dysplasia; Nasal Continuous Positive airway Pressure (CPAP); Nitrogen oxide (NO); Reference material
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Premature Birth; Obstetric Labor, Premature; Bronchopulmonary Dysplasia
• Other Study ID Numbers: H-4-2012-091