Lung Diseases Clinical Trial
To compare the efficacy and safety of high frequency ventilation (HFV) with that of standard, mechanical ventilation in premature infants of less than 2000 grams.
BACKGROUND:
In the early 1980s, there was increasing concern that the dramatic improvement in the
survival of immature infants had been accompanied by an increase in incidence of pulmonary
complications, some seriously crippling and eventually fatal. Both barotrauma and oxygen
toxicity had been considered in the pathogenesis of these disorders; circulatory disorders
as a result of failure of closure of the ductus arteriosus or fluid overload had also been
proposed as contributory factors. Reports of successful application of the principles of
high frequency ventilation (HFV) in the treatment of infants with RDS and particularly those
with severe interstitial emphysema raised hopes that this technique might prevent barotrauma
to the lungs and stimulated physicians and engineers to develop new equipment useful in
ventilating small infants.
Although HFV had not been evaluated either with regard to efficacy or safety and although
results of fundamental studies had not provided a good understanding of how gas exchange
occurred during HFV, there was considerable interest in introducing this type of ventilatory
support in neonatal intensive care. HFV involves the use of small tidal volumes, delivered
at respiratory frequencies ranging from 1 to 40 Hz with the aid of, for example, a piston
pump or a high speed jet of gas. Compared to conventional mechanical ventilation, HFV offers
several potential advantages, including reduced intrapulmonary pressure swings and
fluctuation in alveolar pressures and the possibility of lowered levels of inspired oxygen.
At that time, theories suggested that HFV produced a pattern of flow that enhanced gas
mixing and 'homogenized' the distribution of ventilation. Experimental observations in adult
animals (cats, dogs and rabbits) or healthy newborn lambs had shown HFV to be effective in
promoting gas exchange without apparent adverse effects. Studies in prematurely delivered
subhuman primates, that develop RDS and subsequently bronchopulmonary dysplasia
indistinguishable from that of human infants, supported the notion the HFV could provide
better oxygenation and lower C02 levels than conventional mechanical ventilation at similar
mean airway pressure. The HIFI trial provided badly needed controlled data on the safety and
efficacy of HFV in premature infants.
Phase I, the Planning Phase, was initiated in August 1984. Recruitment and intervention
began in February 1986 and ended in March 1987. Follow-up studies continued thru September
1988.
DESIGN NARRATIVE:
Subjects were randomized to either standard mechanical ventilation or high frequency
ventilation. The principal endpoint was the incidence of bronchopulmonary dysplasia defined
as: the need for supplemental oxygen on the 28th postnatal day and for more than 21 of the
first 28 days after birth; and abnormal chest radiographic findings that persisted until the
28th day of age. Other endpoints included the need for ventilatory support, the incidence of
crossover from one form of ventilatory support to the other, and mortality rate before the
28th day of postnatal age. Adverse effects considered were pulmonary air leaks, severe
intracranial hemorrhage, and periventricular leukomalacia.
;
Allocation: Randomized, Primary Purpose: Treatment
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