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Cochrane Database of Systematic Reviews Protocol - Intervention

Sustained inflations for neonatal resuscitation

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

In newly born infants resuscitated with intermittent positive pressure ventilation does the provision of initial sustained (greater than 1 second duration) inflations reduce mortality and morbidity?

Subgroup analysis will be performed to determine

  • the safety and efficacy of sustained inflations during resuscitation in subgroups of term (37 weeks gestation and above) and preterm (less than 37 weeks) infants

  • the safety and efficacy of sustained inflations during resuscitation in subgroups determined by the type of ventilation device used (self‐inflating bag, flow‐inflating bag, T‐piece, mechanical ventilator)

  • the safety and efficacy of sustained inflations during resuscitation in subgroups determined by the interface (ie. face mask, endotracheal tube, nasopharyngeal tube) used

  • the safety and efficacy of sustained inflations during resuscitation in subgroups determined by the duration of the sustained inflation ‐ ie. greater than one second to five seconds, greater than five seconds

Background

Adequate ventilation is the key to successful neonatal resuscitation (ILCOR 1999; ILCOR 2000). The Neonatal Subcommittee of the International Liaison Committee on Resuscitation (ILCOR) have produced consensus statements on neonatal resuscitation which advise that infants who have absent or inadequate respiratory efforts and or bradycardia should receive positive pressure ventilation (ILCOR 1999; ILCOR 2000). Use of a manual ventilation device with a face mask is advised, though it is noted that ventilation via an endotracheal tube may be indicated at several points during neonatal resuscitation. The types of manual ventilation devices described are the self‐inflating bag and the flow‐inflating (or anaesthetic) bag. The T‐piece device is mentioned in a list of suggested equipment but not described further.

Self‐inflating bags automatically re‐expand after compression due to their own elastic recoil. While a compressed gas source is not required for these bags to function, oxygen and a reservoir are normally attached to facilitate the delivery of high concentration of oxygen in the inspired gas. The maximum peak inspiratory pressure that can be delivered is limited by a pressure‐release or "pop‐off" valve. Self‐inflating bags do not themselves provide PEEP, though a PEEP valve may be fitted to certain models. The most commonly used self‐inflating bag, the Laerdal Infant Resuscitator (O'Donnell 2004a; O'Donnell 2004b), is of insufficient size to sustain an inflation greater than 1 second (ILCOR 2000).

Flow‐inflating bags depend on a compressed gas source to inflate the bag during use. These devices, which should only be used with a manometer in the circuit (ILCOR 1999; ILCOR 2000), allow for the application of a greater range of PIP. They may also be used to provide a positive end‐expiratory pressure (PEEP) by means of controlling rate of gas escape at the outlet from the bag. Inflations of greater than one second may be delivered with flow‐inflating bags.

T‐pieces also require a compressed gas source to function. The gas flows into a face mask or ETT through an 'inlet' arm and inflation is achieved by interrupting the escape of gas through the outlet. The PIP is usually monitored with a manometer and a safety blow‐off valve is usually included in the circuit. PEEP may be delivered by controlling the rate of gas escape from the outlet. The length of inflation is determined by the duration of occlusion of the outlet and may easily exceed one second.

While not described in ILCOR guidelines, respiratory support of infants in the delivery room using a mechanical ventilator (as opposed to a manual ventilation device) and nasopharyngeal tube (as opposed to a face mask or endotracheal tube) has been described (Lindner 1999).

At birth infants' lungs are filled with fluid which must be cleared for effective respiration to occur. Most newly born infants achieve this spontaneously and may use considerable negative pressures (up to ‐50cmH2O) for initial inspirations (Karlberg 1962; Milner 1977). However, it is estimated that 3‐5% of newly born infants receive some help to breathe at delivery (Saugstad 1998). In a study of 20 term infants delivered by Caesarean section under general anaesthesia resuscitated via an endotracheal tube, it was noted from respiratory traces obtained that gas continued to enter the lung at the end of a standard 1 second inflation (Boon 1979). Based on this observation, a non‐randomised study of the resuscitation of nine term infants in the delivery room using a T‐piece device via an endotracheal tube was performed. It showed that an initial five second inflation with a T‐piece produced a two‐fold increase in inflation volume compared to standard resuscitation techniques and always led to the formation of a functional residual capacity (Vyas 1981). Citing these studies, a report described the effects of a change in management strategy of extremely low birth weight infants in the delivery room (Lindner 1999). The new management strategy included the introduction of an intial sustained inflation of 15 seconds with a mechanical ventilator via a nasopharyngeal tube. This change in strategy resulted in a reduction in the proportion of infants intubated for ongoing respiratory support without apparent increases in adverse outcomes.

ILCOR note that some experts suggest very long inflation times (two to three seconds) for initial inflations, but state this has not been accepted for universal recommendation (ILCOR 1999; ILCOR 2000).

Objectives

In newly born infants resuscitated with intermittent positive pressure ventilation does the provision of initial sustained (greater than 1 second duration) inflations reduce mortality and morbidity?

Subgroup analysis will be performed to determine

  • the safety and efficacy of sustained inflations during resuscitation in subgroups of term (37 weeks gestation and above) and preterm (less than 37 weeks) infants

  • the safety and efficacy of sustained inflations during resuscitation in subgroups determined by the type of ventilation device used (self‐inflating bag, flow‐inflating bag, T‐piece, mechanical ventilator)

  • the safety and efficacy of sustained inflations during resuscitation in subgroups determined by the interface (ie. face mask, endotracheal tube, nasopharyngeal tube) used

  • the safety and efficacy of sustained inflations during resuscitation in subgroups determined by the duration of the sustained inflation ‐ ie. greater than one second to five seconds, greater than five seconds

Methods

Criteria for considering studies for this review

Types of studies

All randomised and quasi‐randomised controlled trials will be included

Types of participants

Term and preterm infants resuscitated using positive pressure ventilation at birth.

Types of interventions

Resuscitation with initial sustained (> 1 second) inflations versus resuscitation with regular (less than or equal to 1 second) inflations.

Types of outcome measures

The primary outcomes for this review will be:

  • Death in the delivery room

  • Death during hospitalisation or to latest follow‐up

The secondary outcomes for this review will be:

  • Apgar scores at one and five minutes

  • Heart rate at five minutes

  • Endotracheal intubation in the delivery room

  • Endotracheal intubation outside the delivery room during hospitalisation

  • Duration in hours of respiratory support ie. nasal continuous airway pressure and ventilation via an endotracheal tube considered separately and in total

  • Duration in days of supplemental oxygen requirement

  • Chronic lung disease: the need for supplemental oxygen at 28 days of life; the need for supplemental oxygen at 36 weeks gestational age for infants born at or before 32 weeks gestation

  • Air leaks (pneumothorax, pneumomediastinum, pneumopericardium, pulmonary interstitial emphysema) reported either individually or as a composite outcome

  • Seizures including clinical and electroencephalographic

  • Hypoxic ischaemic encephalopathy (grade I‐III ‐ Sarnat 1976)

  • Cranial ultrasound abnormalities: any intraventricular haemorrhage (IVH), grade 3 or 4 (IVH) according to Papile classification (Papile 1978) and cystic periventricular leukomalacia

  • Long term neurodevelopmental outcome (rates of cerebral palsy on physician assessment, developmental delay, ie. IQ 2 standard deviations less than the mean on validated assessment tools eg Bayley's Mental Developmental Index)

Search methods for identification of studies

The standard search strategy of the Cochrane Neonatal Group will be used. PubMed (1966 to 2004) and CINAHL (1982 to 2004) will be searched using the MeSH headings "Infant, Newborn", "Resuscitation", "Respiration, Artificial" and the textwords "sustained inflations" and "prolonged inflations". The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2004) will be searched using textwords Newborn and Resuscitation. No language restrictions will be applied. The abstracts of the Society for Pediatric Research, and the European Society for Pediatric Research will be searched from 1995‐2004.

Data collection and analysis

The standard methods of the Neonatal Review Group of the Cochrane Collaboration will be employed. Trial searches, assessments of methodology and extraction of data will be performed independently by each reviewer with comparison and resolution of any differences found at each stage. Methodology will be assessed regarding blinding of randomisation, intervention and outcome measurements as well as completeness of follow‐up. Where any queries arise or where additional data are required, the authors will be contacted. Categorical data (e.g. number dying or developing bronchopulmonary dysplasia) will be extracted for each intervention group, and relative risk (RR), relative risk reduction, risk difference (RD) and number needed to treat (NNT) calculated. Mean and standard deviation will be obtained for continuous data (e.g. number of days of respiratory support, or duration of oxygen dependency) and analysis performed using the weighted mean difference (WMD). The fixed effect model will be applied. Heterogeneity will be evaluated using the I2 statistic to determine the suitability of pooling results. We plan subgroup analyses according to gestational age (< 37 weeks, 37 weeks and above), ventilation device used (self‐inflating bag, flow‐inflating bag, T‐piece, mechanical ventilator), patient interface used (face mask, endotracheal tube, nasopharyngeal tube) and duration of sustained inflation (> one second to five seconds, > five seconds).