Sustained inflations versus UK standard inflations during initial resuscitation of prematurely born infants in the delivery room: a study protocol for a randomised controlled trial. 2017

Katie A Hunt, and Kamal Ali, and Theodore Dassios, and Anthony D Milner, and Anne Greenough
Division of Asthma, Allergy and Lung Biology, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, Kings College London, London, UK.

BACKGROUND Many 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. METHODS This 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. CONCLUSIONS This is the first study to compare a sustained inflation to the current UK practice of five initial inflations of 2-3 s. BACKGROUND ClinicalTrials.gov, NCT02967562 . Registered on 15 November 2016.

UI MeSH Term Description Entries
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D007234 Infant, Premature A human infant born before 37 weeks of GESTATION. Neonatal Prematurity,Premature Infants,Preterm Infants,Infant, Preterm,Infants, Premature,Infants, Preterm,Premature Infant,Prematurity, Neonatal,Preterm Infant
D008131 London The capital of the United Kingdom. It is located in England.
D008168 Lung Either of the pair of organs occupying the cavity of the thorax that effect the aeration of the blood. Lungs
D012107 Research Design A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly. Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D012121 Respiration, Artificial Any method of artificial breathing that employs mechanical or non-mechanical means to force the air into and out of the lungs. Artificial respiration or ventilation is used in individuals who have stopped breathing or have RESPIRATORY INSUFFICIENCY to increase their intake of oxygen (O2) and excretion of carbon dioxide (CO2). Ventilation, Mechanical,Mechanical Ventilation,Artificial Respiration,Artificial Respirations,Mechanical Ventilations,Respirations, Artificial,Ventilations, Mechanical
D012151 Resuscitation The restoration to life or consciousness of one apparently dead. (Dorland, 27th ed) Resuscitations
D002985 Clinical Protocols Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy. Protocols, Clinical,Research Protocols, Clinical,Treatment Protocols,Clinical Protocol,Clinical Research Protocol,Clinical Research Protocols,Protocol, Clinical,Protocol, Clinical Research,Protocols, Clinical Research,Protocols, Treatment,Research Protocol, Clinical,Treatment Protocol
D003696 Delivery Rooms Hospital units equipped for childbirth. Birthing Centers, Hospital,Birth Centers, Hospital,Center, Hospital Birth,Center, Hospital Birthing,Centers, Hospital Birth,Centers, Hospital Birthing,Delivery Room,Hospital Birth Centers,Hospital Birthing Centers,Room, Delivery,Rooms, Delivery,Birth Center, Hospital,Birthing Center, Hospital,Hospital Birth Center,Hospital Birthing Center
D005865 Gestational Age The age of the conceptus, beginning from the time of FERTILIZATION. In clinical obstetrics, the gestational age is often estimated from the onset of the last MENSTRUATION which is about 2 weeks before OVULATION and fertilization. It is also estimated to begin from fertilization, estrus, coitus, or artificial insemination. Embryologic Age,Fetal Maturity, Chronologic,Chronologic Fetal Maturity,Fetal Age,Maturity, Chronologic Fetal,Age, Embryologic,Age, Fetal,Age, Gestational,Ages, Embryologic,Ages, Fetal,Ages, Gestational,Embryologic Ages,Fetal Ages,Gestational Ages

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