1378 CLINICAL TRIAL OF TRACHEAL INSTILLATION OF CALFLUNG LIPID (CLL) AT BIRTH T0 PREVENT HYALINE MEMBRANE DISEASE (HMD)

Abstract

A double blind clinical trial is in progress to determine if 100 mg of CLL instilled into the. trachea of 24-28 weeks gestation infants who had no prenatal steroid treatment can prevent HMD. The trial has been conducted at Children's Hospital of Buffalo between 6-1-83 and 7-31-84. During the 14 months, 24 patients were enrolled in the trial, 24 were excluded because of prenatal steroid treatment. HMD was prospectively defined as death before 48 hours or an infant at 48 hours of age with x-ray criteria, on more than 20 breaths/min of artificial ventilation, mean airway pressure >7 torr, and FiO₂ >0.3. The CLL treated group had a 17% incidence of HMD and the saline control group 60% (p=.043 Fisher's exact test). The incidence of HMD was 25% in prenatal steroid treated infants, and 76% in. those unenrolled who did not receive prenatal steroids. Among survivors CLL treated infants had a lower incidence of bronchopulmonary dysplasia than saline controls, 18% to 63% (p=.06 Fisher's exact test). The CLL treated group had fewer deaths, intraventricular hemorrhages, and air leaks, but these were not enough different to reach statistical significance with the present numbers. Patent ductus arteriosus incidence was the same in all groups. CLL instillation at birth. appears to induce a major reduction in the incidence of HMD and in some or many of. its related complications in extremely premature infants.

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