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Trial · NCT06401083

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRate of extubation failure48 hoursReintubation. The discretion of the attending physician.
SecondaryFrequency of apneas48 hoursRespiratory failure of 15-20 seconds or shorter duration associated with bradycardia or desaturation.
SecondaryChange in the mean heart rate72 hoursMean heart rate measured 24 hours before and 48 hours after intervention.
SecondaryTachycardia72 hoursThe time interval when the heart rate \>200 (min) during one day (1440 min) in percentage.
SecondaryVolume of gastric residuals72 hoursGastric residuals measured 24 hours before and 48 hours after intervention.
SecondaryReduction/Cessation of feeding48hours48 hours after intervention.
SecondaryChange in mean arterial blood pressure48 hoursMean blood pressure measured 24 hours before and after intervention measured with non-invasive methods.
SecondaryMechanical ventilation (MV) daysAt discharge from participating centres, an average of one month.MV days during the length of hospital stay
SecondaryNon-invasive ventilation (NIV) daysAt discharge from participating centres, an average of one month.NIV days during the length of hospital stay
SecondaryRate of necrotizing enterocolitisAt discharge from participating centres, an average of one month.Development of necrotizing enterocolitis according to Bell stages.
SecondaryRate of Intraventricular hemorrhageAt discharge from participating centres, an average of one month.Development or progression of intraventricular hemorrhage according to Papile stages diagnosed with cranial ultrasound.
SecondaryRate of periventricular leukomalaciaAt discharge from participating centres, an average of one month.Development of periventricular leukomalacia, seen on cranial ultrasound.
SecondaryRate of late-onset sepsisAt discharge from participating centres, an average of one month.Culture proven sepsis after the first 72 hours of life.
SecondaryRate of patent ductus arteriosusAt discharge from participating centres, an average of one month.Pharmacological or surgical treatment was required.
SecondaryRate of bronchopulmonary dysplasia36th postmenstrual ageDiagnosis of bronchopulmonary dysplasia.
SecondaryRate of death before dischargeAt discharge from participating centres, an average of one month.
SecondaryRequired oxygen concentration24 hoursRequired oxygen concentration before and after the intervention.
SecondaryLong term neurodevelopmental outcomeAt 2 years of corrected ageMeasured by Bayley score. The standardized mean score is 100 (SD 15), with scores lower than 85 indicating mild impairment, and lower than 70 indicating moderate or severe impairment.
SecondarySeverity of sensoric or motoric impairmentAt 2 years of corrected ageHearing or visual impairment, and cerebral palsy

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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