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ASSESSMENT OF PAIN AND DISCOMFORT DURING LESS INVASIVE SURFACTANT ADMINISTRATION

ASSESSMENT OF PAIN AND DISCOMFORT DURING LESS INVASIVE SURFACTANT ADMINISTRATION

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00022317
Enrollment
100
Registered
2020-09-07
Start date
2020-08-10
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

P22.0 P07.0 P07.1

Interventions

Group 1: Premature infants 22+0 weeks of gestational age - 32+0 weeks of gestational age who receive primary or secondary surfactant on the first day of life via less-invasive surfactant administratio

Sponsors

Neonatologie der Medizinischen Universität Wien
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Preterm infants =32+0 weeks of gestation born at the Department of Neonatology of the Medical University Vienna, Austria or Cologne University hospital, Germany with RDS and the need for surfactant replacement will be included in the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria will be infants with major congenital malformations/syndromes as well as conditions that do not allow LISA but require emergency intubation such as severe haemodynamic compromise, pneumothorax or prolonged apnea >2 min.

Design outcomes

Secondary

MeasureTime frame
Is pain and discomfort perceived differently in preterms of different gestational age groups?

Primary

MeasureTime frame
Are non-pharmacological measures sufficient to achieve "comfort" and analgesia ( assessed by neo comfort score and N-PASS) during the LISA procedure - within the first hour of life up to a maximum during the first day of life - in small premature babies from 22+0 to 32+0 weeks of pregnancy?

Countries

Austria, Germany

Contacts

Public ContactBenjamin Kühne

Uniklinik KölnKlinik für Kinder- und Jugendmedizin

benjamin.kuehne@uk-koeln.de0221 47885699

Outcome results

None listed

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