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

NCT ID: NCT01722760

Last Updated: 2015-11-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-11-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Term and preterm infants

Term and preterm infants

measurements

Intervention Type: PROCEDURE

Interventions

measurements

Intervention Type: PROCEDURE

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

• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Birgitte Johanne Schmidt

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Birgitte J Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Children´s Dep, North Zealand Hospital Hilleroed, Denmark

Locations

Neonatal departement GN, Rigshospitalet

Copenhagen, Region H, Denmark

Children´s Departement, North Zealand Hospital, Hilleroed

Hilleroed, Region H, Denmark

Countries

Denmark

Other Identifiers

H-4-2012-091

Identifier Type: -

Identifier Source: org_study_id