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Trials. 2016 Aug 18;17:414. doi: 10.1186/s13063-016-1498-7.

Efficacy of a new technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - in preterm neonates with respiratory distress syndrome: study protocol for a randomized controlled trial.

Author information

1
Division of Neonatology, Department for the Protection of Women's Health and the Nascent Life, Child and Adolescent, Policlinico A. Gemelli - Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy. giovanni.vento@unicatt.it.
2
Section of Hygiene, Institute of Public Health, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, 00168, Rome, Italy.
3
Clinical Trials Coordinating Center of Istituto Toscano Tumori, Department of Oncology, Careggi University Hospital, Largo Brambilla 3, 50134, Florence, Italy.
4
Division of Neonatology, Department for the Protection of Women's Health and the Nascent Life, Child and Adolescent, Policlinico A. Gemelli - Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.
5
Division of Neonatology, Department of Clinical Sciences, Polytechnic University of Marche and Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona, Italy.
6
Department of Neonatology, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090, Brussels, Belgium.
7
Department of Surgical and Medical Critical Care, Section of Neonatology, Careggi University Hospital, Viale Morgagni 85, 50141, Florence, Italy.
8
Department of Clinical Sciences and Community Health, University of Milan-Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Della Commenda 12, 20122, Milan, Italy.
9
School of Anatomy, Physiology and Human Biology, University of Western Australia, Crawley, WA, Australia.
10
The Ritchie Centre Hudson Institute of Medical Research and Department of Obstetrics and Gynaecology, Monash University, Clayton, 3168, VIC, Australia.
11
Fondazione MBBM - Ospedale San Gerardo, Monza, Italy.
12
Department of Neonatology, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands.
13
Ospedale San Pietro Fatebenefratelli, Rome, Italy.
14
Ospedale S. Giovanni Calibita Fatebenefratelli Isola Tiberina, Rome, Italy.
15
Università di Roma "La Sapienza"/Policlinico Umberto I, Rome, Italy.
16
Ospedale Belcolle, Viterbo, Italy.
17
Fondazione Poliambulanza, Brescia, Italy.
18
Ospedale Niguarda Cà Granda, Milan, Italy.
19
Azienda Ospedaliera Carlo Poma, Mantova, Italy.
20
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
21
Azienda Ospedaliero Universitaria Maggiore della Carità, Novara, Italy.
22
Azienda Ospedaliero-Universitaria Ospedali Riuniti, Foggia, Italy.
23
Azienda Ospedaliera Vito Fazzi, Lecce, Italy.
24
Ospedale Evangelico Villa Betania, Naples, Italy.
25
Careggi University Hospital, Florence, Italy.
26
Casa di Cura Pineta Grande, Castelvolturno (CE), Italy.
27
Azienda Ospedaliera Sant' Anna e San Sebastiano, Caserta, Italy.
28
Ospedale Maggiore, Bologna, Italy.
29
Azienda Ospedaliero-Universitaria Arcispedale S. Anna, Ferrara, Italy.
30
Azienda Ospedaliera di Cosenza, Cosenza, Italy.
31
Ospedale Di Venere, Bari, Italy.
32
A.O.R.N. "G. RUMMO", Benevento, Italy.
33
Ospedale Panico, Tricase (LE), Italy.
34
Ospedale di Bolzano, Bolzano, Italy.
35
Azienda Ospedaliera Arcispedale S.Maria Nuova di Reggio Emilia/IRCCS, Reggio Emilia, Italy.
36
Polytechnic University of Marche and Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona, Italy.
37
Ospedale Barone Romeo, Patti (ME), Italy.
38
Azienda Ospedaliera-Universitaria di Parma, Parma, Italy.
39
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele- PO G. Rodolico, Catania, Italy.
40
Azienda Ospedaliero-Universitaria Policlinico "G. Martino", Messina, Italy.
41
Azienda Ospedaliera di rilievo nazionale e di alta specializzazione Arnas Civico, Palermo, Italy.
42
Ospedale San Bortolo, Vicenza, Italy.
43
Azienda Ospedaliera-Universitaria di Modena, Modena, Italy.
44
Ospedale San Salvatore, L'Aquila, Italy.
45
Azienda ospedaliera "Bianchi-Melacrino-Morelli", Reggio Calabria, Italy.
46
Ospedale Santa Maria di Ca' Foncello di Treviso, Treviso, Italy.

Abstract

BACKGROUND:

Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 %. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E method, requiring subsequent re-intubation and mechanical ventilation, is the inability of the preterm lung to achieve and maintain an "optimal" functional residual capacity. The importance of lung recruitment before surfactant administration has been demonstrated in animal studies showing that recruitment leads to a more homogeneous surfactant distribution within the lungs. Therefore, the aim of this study is to compare the application of a recruitment maneuver using the high-frequency oscillatory ventilation (HFOV) modality just before the surfactant administration followed by rapid extubation (INtubate-RECruit-SURfactant-Extubate: IN-REC-SUR-E) with IN-SUR-E alone in spontaneously breathing preterm infants requiring nasal continuous positive airway pressure (nCPAP) as initial respiratory support and reaching pre-defined CPAP failure criteria.

METHODS/DESIGN:

In this study, 206 spontaneously breathing infants born at 24(+0)-27(+6) weeks' gestation and failing nCPAP during the first 24 h of life, will be randomized to receive an HFOV recruitment maneuver (IN-REC-SUR-E) or no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation. The primary outcome is the need for mechanical ventilation within the first 3 days of life. Infants in both groups will be considered to have reached the primary outcome when they are not extubated within 30 min after surfactant administration or when they meet the nCPAP failure criteria after extubation.

DISCUSSION:

From all available data no definitive evidence exists about a positive effect of recruitment before surfactant instillation, but a rationale exists for testing the following hypothesis: a lung recruitment maneuver performed with a step-by-step Continuous Distending Pressure increase during High-Frequency Oscillatory Ventilation (and not with a sustained inflation) could have a positive effects in terms of improved surfactant distribution and consequent its major efficacy in preterm newborns with respiratory distress syndrome. This represents our challenge.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT02482766 . Registered on 1 June 2015.

KEYWORDS:

HFOV; INSURE; Lung recruitment; Preterm infants

PMID:
27538798
PMCID:
PMC4991115
DOI:
10.1186/s13063-016-1498-7
[Indexed for MEDLINE]
Free PMC Article

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