Effectiveness of the Fentanyl in continuous infusion in the newborns in mechanical ventilation - NEO 01/2005

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-006140-37-IT

Enrollment

129

Registered

2007-07-13

Start date

2006-05-09

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

intubation of the respiratory tract MedDRA version: 6.1 Level: PT Classification code 10002093

Interventions

Trade Name: FENTANEST*INIET 5F 2ML 0,1MG Pharmaceutical Form: Solution for infusion INN or Proposed INN: Fentanyl CAS Number: 990-73-8 Concentration unit: µg microgram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Newborns of EG =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Great malformations; Asphyxia; Strict IVH;

Design outcomes

Primary

Measure	Time frame
Secondary Objective: 1. Proportion of newborns in VM to 1 week of life 2. Age of attainment of the enteral feeding total 3. Age (hours) to which it comes emitted meconium 4. Incidence of IVH, PVL or death within 28 days of life 5. Vesical globe incidence 6. Incidence of hypotension;Main Objective: To estimate the analgesic effectiveness of the fentanyl by the application of validated scales in the newborns for the chronic pain and the procedural pain.;Primary end point(s): analgesic effectiveness of the fentanyl	—

Measure

Time frame

Secondary Objective: 1. Proportion of newborns in VM to 1 week of life 2. Age of attainment of the enteral feeding total 3. Age (hours) to which it comes emitted meconium 4. Incidence of IVH, PVL or death within 28 days of life 5. Vesical globe incidence 6. Incidence of hypotension;Main Objective: To estimate the analgesic effectiveness of the fentanyl by the application of validated scales in the newborns for the chronic pain and the procedural pain.;Primary end point(s): analgesic effectiveness of the fentanyl

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Countries

Italy

Outcome results

None listed

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