The effect of additional loading dose of caffeine-citrate prior ro extubation

The effect of additional pre-extubational loading dose of caffeine-citrate - NEOKOFF22

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003202-77-HU

Enrollment

242

Registered

2023-02-03

Start date

2023-04-04

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extubation failure and bronchopulmonary dysplasia MedDRA version: 20.0 Level: LLT Classification code 10002973 Term: Apnea neonatal System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1 Level: LLT Classification code 10071132 Term: Primary apnea of premature newborns System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10077322 Term: Infantile apnea System Organ Class: 1

Interventions

Trade Name: CITRATE DE CAFEINE COOPER Product Name: CITRATE DE CAFEINE COOPER Product Code: 34009 345 359 3 2 Pharmaceutical Form: Injection/infusion INN or Proposed INN: Caffeine citrate CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm neonates born before the 32nd week of gestation and had been mechanicaly ventillated for at least 48 hours. Before the first planned extubation. Are the trial subjects under 18? yes Number of subjects for this age range: 226 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Lack of consent. Preterm neonate with major congenital anomaly. Did not recieved surfactant therapy. Hydrops foetalis. Persistent tachycardia prior to extubation, foetal/neonatal arrhytmia. Asphyxia.

Design outcomes

Primary

Measure	Time frame
Main Objective: Our objective was to investigate wether an additional pre extubational loading dose of caffeine-citrate change the extubation success rate.;Secondary Objective: In addition, we want to assess the frequency and severity of side effects. Our objectives include investigating the effect of caffeine-citrate on the development of BPD and IVH and PVL, as well as on the progression of IVH.;Primary end point(s): Reintubation;Timepoint(s) of evaluation of this end point: First 48 hours after extubation.	—

Measure

Time frame

Main Objective: Our objective was to investigate wether an additional pre extubational loading dose of caffeine-citrate change the extubation success rate.;Secondary Objective: In addition, we want to assess the frequency and severity of side effects. Our objectives include investigating the effect of caffeine-citrate on the development of BPD and IVH and PVL, as well as on the progression of IVH.;Primary end point(s): Reintubation;Timepoint(s) of evaluation of this end point: First 48 hours after extubation.

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Secondary

Measure	Time frame
Secondary end point(s): Frequency of apnoeas. Side effects (elevated heart rate, elevated blood pressure, gastric residuals) Necrotizing enterocolitis. Bronchopulmonary dysplasia. The progression or development of intraventricular hemorrhage or periventricular leukomalacia. Neurodevelopmental outcome.;Timepoint(s) of evaluation of this end point: Frequency of apnoeas within the next 48 hours. Side effects: first 48 hours after extubation. Necrotizing enterocolitis: before discharge. Bronchopulmonary dysplasia: 36th week of postmenstrual age. The progression or development of intraventricular hemorrhage or periventricular leukomalacia: the last cranial ultrasound before discharge. Neurodevelopmental outcome at 2 years of age.	—

Measure

Time frame

Secondary end point(s): Frequency of apnoeas. Side effects (elevated heart rate, elevated blood pressure, gastric residuals) Necrotizing enterocolitis. Bronchopulmonary dysplasia. The progression or development of intraventricular hemorrhage or periventricular leukomalacia. Neurodevelopmental outcome.;Timepoint(s) of evaluation of this end point: Frequency of apnoeas within the next 48 hours. Side effects: first 48 hours after extubation. Necrotizing enterocolitis: before discharge. Bronchopulmonary dysplasia: 36th week of postmenstrual age. The progression or development of intraventricular hemorrhage or periventricular leukomalacia: the last cranial ultrasound before discharge. Neurodevelopmental outcome at 2 years of age.

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Countries

Hungary

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026