CAFFEINE TREATMENT IN DELIVERY ROOM FOR VERY PRETERM INFANTS : A FEASIBILITY STUDY

CAFFEINE TREATMENT IN DELIVERY ROOM FOR VERY PRETERM INFANTS : A FEASIBILITY STUDY - CAFFEINE IN DELIVERY ROOM

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003626-91-IT

Enrollment

Registered

2020-11-04

Start date

2019-04-09

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

25+0-29+6 gestational age preterm infants at risk of respiratory distress syndrome with no need of mechanical ventilation in delivery room. MedDRA version: 21.0 Level: LLT Classification code 10021734 Term: Infant premature System Organ Class: 100000004868

Interventions

Trade Name: PEYONA - 20MG/ML - SOLUZIONE PER INFUSIONE E SOLUZIONE ORALE - PER SOMMINISTRAZIONE ENDOVENOSA E ORALE - FLACONCINO(VETRO) 10 FLACONCINI DA 3 ML Product Name: Peyona Product Code: [4088901

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 25+0-29+6 gestational age preterm infants with no need of mechanical ventilation in delivery room. 2. parental informed consent Are the trial subjects under 18? yes Number of subjects for this age range: 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: 1. Neonates born from mothers that assumed high quantity of caffeine (more than 2 cups of coffee in 6 hours before the delivery) 2. Major congenital malformation, cromosomal syndrome, Inborn errors of the metabolism 3. Hydrops fetalis

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the feasibility of the administration of intravenous or enteral caffeine in delivery room.;Secondary Objective: Comparison of intravenous administration vs enteral administration Evaluation of need of mechanical ventilation in treated newborn;Primary end point(s): Numbers of neonates that successfully received intravenous or enteral caffeine in the first 10 minutes of life.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: To evaluate the feasibility of the administration of intravenous or enteral caffeine in delivery room.;Secondary Objective: Comparison of intravenous administration vs enteral administration Evaluation of need of mechanical ventilation in treated newborn;Primary end point(s): Numbers of neonates that successfully received intravenous or enteral caffeine in the first 10 minutes of life.;Timepoint(s) of evaluation of this end point: 12 months

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Secondary

Measure	Time frame
Secondary end point(s): Number of succesful achievement of therapeutic range at the second dosage (before the second caffeine administration); Number of succesful caffeine administration in the delivery room, defined as therapy administration in the expected time;; Number of successful achievement of therapeutic range at the first dosage; Comparison between caffein blood level in enteral caffeine administration vs intravenous caffeine administration; Need of mechanical ventilation in the first 72 hours of live of the treated neonates;Timepoint(s) of evaluation of this end point: 12 months; 12 months; 12 months; 12 months; 12 months	—

Measure

Time frame

Secondary end point(s): Number of succesful achievement of therapeutic range at the second dosage (before the second caffeine administration); Number of succesful caffeine administration in the delivery room, defined as therapy administration in the expected time;; Number of successful achievement of therapeutic range at the first dosage; Comparison between caffein blood level in enteral caffeine administration vs intravenous caffeine administration; Need of mechanical ventilation in the first 72 hours of live of the treated neonates;Timepoint(s) of evaluation of this end point: 12 months; 12 months; 12 months; 12 months; 12 months

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Countries

Italy

Contacts

Public ContactNEONATOLOGIA E TERAPIA INTENSIVA NE

AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI

carlo.dani@unifi.it05579478421

Outcome results

None listed

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