High Frequency Ventilation in Premature Infants (HIFI)

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Brief Title

High Frequency Ventilation in Premature Infants (HIFI)


Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 3

Study Type

Interventional




Condition

Bronchopulmonary Dysplasia

Intervention

high-frequency ventilation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure


Start Date

August 1984



Eligibility Criteria

        Boy and girl infants weighing less than 2000 g. who required mechanical ventilation within
        24 hours of birth and had been treated for less than 12 hours with conventional mechanical
        ventilation before randomization.
      

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

Kenneth Poole, , 



Administrative Informations


NCT ID

NCT00000567

Organization ID

205



Study Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Sponsor

Kenneth Poole, , RTI International


Verification Date

December 2005