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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Distress Syndrome in Premature Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants and data analyst will be masked.

Study Groups

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LISA-analgesic

Less Invasive Surfactant Administration (LISA) with remifentanil (0.5-2 micrograms/kg/dose) as the analgesic drug.

Group Type EXPERIMENTAL

LISA

Intervention Type PROCEDURE

Surfactant (Poractant alfa) will be directly delivered into the lungs via a fine bore catheter inserted into the trachea and then patients will be extubated.

Analgesic, Opioid

Intervention Type DRUG

Remifentanil (0.5-2 micrograms/kg/dose)

LISA-no analgesic

Less Invasive Surfactant Administration (LISA) without an analgesic drug.

Group Type EXPERIMENTAL

LISA

Intervention Type PROCEDURE

Surfactant (Poractant alfa) will be directly delivered into the lungs via a fine bore catheter inserted into the trachea and then patients will be extubated.

INSURE-analgesic

INtubation-SURfactant-Extubation (INSURE) with remifentanil (0.5-2 micrograms/kg/dose) as the analgesic drug.

Group Type EXPERIMENTAL

INSURE

Intervention Type PROCEDURE

Patients will be intubated by endotracheal tube, exogenous surfactant (Poractant alfa) will be administered and then they will be extubated.

Analgesic, Opioid

Intervention Type DRUG

Remifentanil (0.5-2 micrograms/kg/dose)

INSURE-no analgesic

INSURE without an analgesic drug.

Group Type EXPERIMENTAL

INSURE

Intervention Type PROCEDURE

Patients will be intubated by endotracheal tube, exogenous surfactant (Poractant alfa) will be administered and then they will be extubated.

Interventions

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INSURE

Patients will be intubated by endotracheal tube, exogenous surfactant (Poractant alfa) will be administered and then they will be extubated.

Intervention Type PROCEDURE

LISA

Surfactant (Poractant alfa) will be directly delivered into the lungs via a fine bore catheter inserted into the trachea and then patients will be extubated.

Intervention Type PROCEDURE

Analgesic, Opioid

Remifentanil (0.5-2 micrograms/kg/dose)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

168 Days

Maximum Eligible Age

223 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No