TY - JOUR
T1 - Sustained inflations versus UK standard inflations during initial resuscitation of prematurely born infants in the delivery room
T2 - a study protocol for a randomised trial
AU - Hunt, Katie Anne
AU - Ali, Kamal Ali Mohammed
AU - Theodore Dassios
AU - Milner, Anthony D.
AU - Greenough, Anne
PY - 2017
Y1 - 2017
N2 - 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.
Discussion: This is the first study to compare a sustained inflation to the current UK practice of five initial inflations of 2–3 s.
AB - 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.
Discussion: This is the first study to compare a sustained inflation to the current UK practice of five initial inflations of 2–3 s.
U2 - 10.1186/s13063-017-2311-y
DO - 10.1186/s13063-017-2311-y
M3 - Article
SN - 1745-6215
JO - Trials
JF - Trials
ER -