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Table 1 Time points of interventions and outcome assessment of outcomes during the study

From: Application of two different nasal CPAP levels for the treatment of respiratory distress syndrome in preterm infants—“The OPTTIMMAL-Trial”—Optimizing PEEP To The IMMAture Lungs: study protocol of a randomized controlled trial

Points of action

Screening

Baseline

Visits

End of inpatient study

Follow-up

End of study

Visit

1

2

3

4

5

6

7

8

9

Time point/age

Prior birth

0 h

120 h

Day 7

PMA 36

Discharge

24 months corrected age

60 months of age

 

Inclusion criteria

●

        

Exclusion criteria

●

        

Informed consent

●

        

Neonatal and maternal characteristics

 Data

 

●

       

Study intervention/ventilation

 Start

 

●

       

 End

  

●

      

 PEEP data

  

●

      

 Surfactant treatment

  

●

      

 Ventilation data

  

●

 

●

●

   

Safety

 Serious adverse events

Continuous reporting until discharge

   

Outcome assessment

 BPD

    

●

    

 Death

    

●

   

●

 ROP

    

●

    

 NEC

    

●

    

 FIP

    

●

    

 PDA

    

●

    

 Nosocomial infections

    

●

    

 Brain injury (CUS)

   

●

●

    

 Feeding data

    

●

    

 Inotropes

    

●

    

 Postnatal steroids

     

●

   

 Bayley III/GMFCS

      

●

  

 Visual and hearing

      

●

  

 Lung function

       

●

 

 WPPSI-III

       

●

 

 Lung/brain MRI

       

●

 

 Parental questionnaire

Every 3  months after discharge

  1. BPD bronchopulmonary dysplasia, CUS cerebral ultrasound, FIP focal intestinal perforation, GMFCS gross motor function classification scale, MRI magnetic resonance imaging, NEC necrotizing enterocolitis, PDA persistent ductus arteriosus, PMA postmenstrual age, ROP retinopathy of prematurity
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Trials

ISSN: 1745-6215