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Stress Assessment With and Without Analgesia During Surfactant Therapy in Preterm Infants.

V

Virgilio Paolo Carnielli

Status and phase

Unknown
Phase 4

Conditions

Respiratory Distress Syndrome in Premature Infants

Treatments

Drug: Analgesic, Opioid
Procedure: LISA
Procedure: INSURE

Study type

Interventional

Funder types

Other

Identifiers

NCT04073173
StrAAS
2020-004269-38 (EudraCT Number)

Details and patient eligibility

About

This study will compare stress, changes in oxygenation and oxidative damage in preterm infants with respiratory distress syndrome (RDS) randomized to receive or not remifentanil as an analgesic drug during the administration of porcine surfactant (poractant alfa, Curosurf®) through the traditional (INSURE) or the less invasive (LISA) method.

Full description

At present, LISA and INSURE are both used for surfactant therapy in infants as comparable methods. However, a clear policy of using analgesics during surfactant therapy is still lacking: some neonatologists use analgesics to reduce stress and pain scores, whereas others do not approve their use due to interference with spontaneous breathing.

In this open-label, randomized, phase 4 clinical trial, infants admitted to our neonatal intensive unit care (NICU) will be evaluated according to the selection criteria and then randomized to receive or not remifentanil as an analgesic drug during the administration of porcine surfactant (poractant alfa, Curosurf®) via the INSURE or LISA method: Group-1) LISA-analgesic; Group 2) LISA-no analgesic; Group-3) INSURE-analgesic; Group-4) INSURE-no analgesic. Study patients will be stratified by gestational age at birth: Block A) 23.0-27.6 weeks of gestation; Block B) 28.0-31.6 weeks of gestation.

Early caffeine administration will be provided according to our NICU guidelines shortly after birth. Infants with adequate respiratory drive will be stabilized on nasal continuous positive airway pressure (CPAP; 4-8 cm of water) right after birth. Oxygen saturation targets will be 90-94%; moderate degrees of hypercarbia (PaCO2 < 60 mmHg, provided arterial pH >7.22) will be tolerated. Conditions mimicking respiratory distress syndrome (RDS; i.e. sepsis, air leaks, aspiration pneumonia, congenital heart disease) will be ruled out. RDS diagnosis will be clinical according to the European Guidelines. Nasal CPAP, bi-level CPAP or nasal intermittent positive pressure ventilation (synchronized or not) will be used at the discretion of the attending physician to stabilize the patients. Intubation criteria according to our NICU guidelines will be:

  1. severe acidosis (defined as arterial pH<7.20 with a partial pressure of carbon dioxide (PaCO2) > 55 mmHg and partial pressure of oxygen (PaO2) < 50 mmHg) with a fraction of inspired oxygen (FiO2) > 0.50;
  2. severe apnoea.

Enrolled infants will be evaluated from birth to day 7 of the hospital stay.

Enrollment

80 estimated patients

Sex

All

Ages

168 to 223 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • gestational age at birth between 168 and 223 days,
  • respiratory distress syndrome (diagnosed on the basis of clinical and/or radiological grounds) with a fraction of inspired oxygen ≥0.30 (for infants born ≤26 weeks' gestational age) or ≥0.40 (for infants born >26 weeks' gestational age) to achieve a peripheral oxygen saturation of 90-94% within 24 hours of life and good respiratory drive,
  • written informed consent.

Exclusion criteria

  • major malformations,
  • late admission (after 24 hours of life),
  • intubation in the delivery room,
  • severe birth asphyxia,
  • prolonged rupture of membranes,
  • air leaks,
  • no informed consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 4 patient groups

LISA-analgesic
Experimental group
Description:
Less Invasive Surfactant Administration (LISA) with remifentanil (0.5-2 micrograms/kg/dose) as the analgesic drug.
Treatment:
Procedure: LISA
Drug: Analgesic, Opioid
LISA-no analgesic
Experimental group
Description:
Less Invasive Surfactant Administration (LISA) without an analgesic drug.
Treatment:
Procedure: LISA
INSURE-analgesic
Experimental group
Description:
INtubation-SURfactant-Extubation (INSURE) with remifentanil (0.5-2 micrograms/kg/dose) as the analgesic drug.
Treatment:
Procedure: INSURE
Drug: Analgesic, Opioid
INSURE-no analgesic
Experimental group
Description:
INSURE without an analgesic drug.
Treatment:
Procedure: INSURE

Trial contacts and locations

0

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Central trial contact

Clementina Rondina, MD; Virgilio Carnielli, MD, PHD

Data sourced from clinicaltrials.gov

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