Dataset Information

Short-term effects of synchronized vs. non-synchronized NIPPV in preterm infants: study protocol for an unmasked randomized crossover trial.

ABSTRACT:

Background

Non-invasive ventilation (NIV) has been recommended as the best respiratory support for preterm infants with respiratory distress syndrome (RDS). However, the best NIV technique to be used as first intention in RDS management has not yet been established. Nasal intermittent positive pressure ventilation (NIPPV) may be synchronized (SNIPPV) or non-synchronized to the infant's breathing efforts. The aim of the study is to evaluate the short-term effects of SNIPPV vs. NIPPV on the cardiorespiratory events, trying to identify the best ventilation modality for preterm infants at their first approach to NIV ventilation support.

Methods

An unmasked randomized crossover study with three treatment phases was designed. All newborn infants < 32 weeks of gestational age with RDS needing NIV ventilation as first intention or after extubation will be consecutively enrolled in the study and randomized to the NIPPV or SNIPPV arm. After stabilization, enrolled patients will be alternatively ventilated with two different techniques for two time frames of 4 h each. NIPPV and SNIPPV will be administered with the same ventilator and the same interface, maintaining continuous assisted ventilation without patient discomfort. During the whole duration of the study, the patient's cardiorespiratory data and data from the ventilator will be simultaneously recorded using a polygraph connected to a computer. The primary outcome is the frequency of episodes of oxygen desaturation. Secondary outcomes are the number of the cardiorespiratory events, FiO₂ necessity, newborn pain score evaluation, synchronization index, and thoracoabdominal asynchrony. The calculated sample size was of 30 patients.

Discussion

It is known that NIPPV produces a percentage of ineffective acts due to asynchronies between the ventilator and the infant's breaths. On the other hand, an ineffective synchronization could increase work of breathing. Our hypothesis is that an efficient synchronization could reduce the respiratory work and increase the volume per minute exchanged without interfering with the natural respiratory rhythm of the patient with RDS. The results of this study will allow us to evaluate the effectiveness of the synchronization, demonstrating whether SNIPPV is the most effective non-invasive ventilation mode in preterm infants with RDS at their first approach to NIV ventilation.

Trial registration

ClinicalTrials.gov NCT03289936 . Registered on September 21, 2017.

SUBMITTER: Cresi F

PROVIDER: S-EPMC8200781 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo compare clinical outcomes of premature infants on synchronized nasal intermittent positive pressure ventilation (SNIPPV) vs nasal intermittent positive pressure ventilation (NIPPV) in the neonatal intensive care unit. Use of NIPPV in the neonatal intensive care unit has shown promise with better clinical outcomes in premature neonates. It is not known if synchronization makes a significant clinical impact when using this technique.Study designRetrospective data were obtained (1/04 to 12/09) of infants who received NIPPV anytime during their stay in the neonatal intensive care unit. SNIPPV (Infant Star with StarSync) was utilized from 2004 to 2006, whereas NIPPV (Bear Cub) was used from 2007 to 2009. Bronchopulmonary dysplasia (BPD) was defined using the NIH consensus definition. Unadjusted associations between potential risk factors and BPD/death were assessed using the χ (2) or Wilcoxon rank-sum test. Adjusted analyses were performed using generalized linear mixed models, taking into account correlation among infants of multiple gestation.ResultThere was no significant difference in the mean gestational age and birth weight in the two groups: SNIPPV (n=172; 27.0w; 1016 g) and NIPPV (n=238; 27.7w; 1117 g). There were no significant differences in maternal demographics, use of antenatal steroids, gender, multiple births, small for gestational age or Apgar scores in the two groups. More infants in the NIPPV group were given resuscitation in the delivery room (SNIPPV vs NIPPV: 44.2 vs 63%, P<0.001). Use of surfactant (84.4 vs 70.2%; P<0.001) was significantly higher in the SNIPPV group. There were no differences in the rate of patent ductus arteriosus, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity and necrotizing enterocolitis in the two groups. After adjusting for the significant variables, use of NIPPV vs SNIPPV (odds ratio 0.74; 95% confidence interval: 0.42, 1.30) was not associated with BPD/death.ConclusionThese data suggest that use of SNIPPV vs NIPPV is not significantly associated with a differential impact on clinical outcomes.