Elsevier

The Journal of Pediatrics

Volume 132, Issue 2, February 1998, Pages 249-254
The Journal of Pediatrics

A prospective, randomized, multicenter trial of high-frequency oscillatory ventilation compared with conventional ventilation in preterm infants with respiratory distress syndrome receiving surfactant,☆☆,

https://doi.org/10.1016/S0022-3476(98)70440-8Get rights and content

Abstract

Objectives: To compare high-frequency oscillatory ventilation (HFOV) and intermittent positive pressure ventilation (IPPV) as a primary ventilation mode in preterm infants with respiratory distress syndrome. Primary end points were survival and maintenance of the randomized ventilation mode.

Study design: Prospective, multicenter, randomized clinical trial.

Setting: Level III neonatal intensive care units at three university children's hospitals.

Patients: Ninety-six premature infants (gestational age < 32 weeks) randomly assigned to HFOV or IPPV within the first 2 hours of life. All patients received a natural surfactant. No differences were found between the study groups with respect to the demographic data or the severity of respiratory distress syndrome. Infants were stratified at randomization, by birth weight, into two groups: 750 to 1000 gm (n = 32) and 1001 to 1500 gm (n = 64). The centers involved complied with a study protocol that planned a reduction in respiratory pressures when the infant's oxygen requirement had reached a fractional concentration of inspired oxygen of 0.6.

Results: Five patients in the HFOV group died, and eight patients did not respond to the randomized ventilation mode; whereas four patients in the IPPV group died, and nine were switched to HFOV. No differences were found in gas exchange or ventilator support over the first 72 hours. Premature infants with a birth weight < 1000 gm had a significantly shorter course to reach fractional concentration of inspired oxygen of 0.21 while receiving IPPV than those receiving HFOV (9.3 ± 4.5 days vs 27.5 ± 10.2 days, p = 0.01). No differences were found between the groups in extraalveolar air (HFOV, seven; IPPV, seven) and intracranial bleeding (HFOV, nine; IPPV, eight).

Conclusion: After surfactant treatment, HFOV, as a primary ventilation mode in premature infants with respiratory distress syndrome, is as safe and efficacious as conventional ventilation. (J Pediatr 1998;132:249-54)

Section snippets

Patients

Three level III centers participated in this trial. The study protocol was approved by the ethics committees of the hospitals involved, and written parental consent was obtained.

Patients were eligible for entry into the study if they weighed between 750 and 1500 gm at birth and exhibited respiratory distress syndrome. All enrolled infants received a natural bovine surfactant (Survanta 100 mg/kg, Abbott GmbH, Wiesbaden, Germany) when the chest x-ray film showed at least RDS II° and FiO2 > 0.6

Results

Between August 1993 and July 1995, 96 premature infants with a gestational age < 32 weeks entered our study. These patients qualified for the trial if chest x-ray films showed at least RDS II° and they needed more than FiO2 0.6 for sufficient oxygenation. The number of patients from the three centers ranged from 11 to 66; there were no center-specific biases in the patients' demographic characteristics, incidence of complications, or outcome. The study was paralleled by a sequential analysis

Discussion

While most previous reports highlighted the role of HFOV as a rescue method in premature infants and the prospective trials allowed an age at study entry from less than 6 hours to less than 48 hours, our trial initiated the randomized branch of ventilation within the first 2 hours of life, thus comparing HFOV and IPPV as primary ventilation modes.

Our ventilatory strategy was aimed at reducing pressures to avoid lung injury. We tried to apply an open lung strategy that we defined as accomplished

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Cited by (0)

From the Department of Pediatrics, Division of Neonatology, University Hospital Frankfurt a. Main, the Department of Pediatrics, University Hospital Cologne, and the Department of Pediatrics, University Hospital Mannheim, Federal Republic of Germany

☆☆

Reprint requests: Werner Rettwitz-Volk, MD, Zentrum der Kinderheilkunde, Abt. f. Neonatologie, Theodor Stern Kai 7, 60590 Frankfurt, Germany.

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