Abstract
BackgroundMany infants born at less than 34 weeks of gestational age will require resuscitation in the delivery suite. Yet, different resuscitation techniques are specified in different national guidelines, likely reflecting a limited evidence base. One difference is the length of mechanical inflation initially delivered to infants either via a facemask or endotracheal tube. Some guidelines specify short inflations delivered at rates of 40–60/min, others recommend initial inflations lasting 2–3 s or sustained inflations lasting for ≥ 5 s for initial resuscitation. Research has shown that tidal volumes > 2.2 mL/kg (the anatomical dead space) are seldom generated unless the infant’s respiratory effort coincides with an inflation (active inflation). When inflations lasting 1–3 s were used, the time to the first active inflation was inversely proportional to the inflation time. This trial investigates whether a sustained inflation or repeated shorter inflations is more effective in stimulating the first active inflation.MethodsThis non-blinded, randomised controlled trial performed at a single tertiary neonatal unit is recruiting 40 infants born at < 34 weeks of gestational age. A 15-s sustained inflation is being compared to five repeated inflations of 2–3 s during the resuscitation at delivery. A respiratory function monitor is used to record airway pressure, flow, expiratory tidal volume and end tidal carbon dioxide (ETCO2) levels. The study is performed as emergency research without prior consent and was approved by the NHS London-Riverside Research Ethics Committee. The primary outcome is the minute volume in the first minute of resuscitation with secondary outcomes of the time to the first active inflation and ETCO2 level during the first minute of recorded resuscitation.DiscussionThis is the first study to compare a sustained inflation to the current UK practice of five initial inflations of 2–3 s.Trial registrationClinicalTrials.gov, NCT02967562. Registered on 15 November 2016.
Highlights
Many infants born at less than 34 weeks of gestational age will require resuscitation in the delivery suite
During resuscitation by facemask or endotracheal tube, tidal volumes and end tidal carbon dioxide (ETCO2) levels remained low until a respiratory effort was made coinciding with a mechanical inflation [3, 6]
= 0.05), but this was not a pre-specified analysis [20]. In contrast to those promising results in moderately or extremely prematurely born infants, in infants born at 34–36 weeks of gestational age there were no significant differences in the need for respiratory support, the incidence of neonatal intensive care unit (NICU) admission for respiratory distress or the total length of Neonatal intensive care centre (NICU) stay between infants who received a 15-s sustained inflation and those who received standard resuscitation according to the American Association of Pediatrics guidelines [21]
Summary
This is a non-blinded, randomised superiority trial. Infants are allocated to parallel groups in a 1:1 ratio. 2. The clinical team present before delivery and trained both in the use of the respiratory function monitor and to deliver sustained inflations. As soon as possible after delivery, parents are approached to inform them about the study and to ask them for written, informed consent for retention and analysis of the respiratory function data. Resuscitation is performed using a t-piece device (Neopuff Infant Resuscitator, Fisher & Paykel Healthcare, Auckland, New Zealand) Both the sustained inflation and the five 2–3 s inflations are performed using a peak inspiratory pressure of 25 cmH2O and PEEP of 5 cm H2O as per unit guidelines. Traces from the respiratory function monitor will be analysed by the investigators to determine minute volume, ETCO2 level and the time to the first active inflation using customised Spectra software (3.0.1.4) (Grove Medical, London, UK). The results of any reports or investigations relating to the events will be communicated to the parents in writing
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