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INTRODUCTION: Previous trials of surfactant therapy in premature infants have demonstrated a survival advantage associated with prophylactic therapy as an immediate bolus, compared with the rescue treatment of established respiratory distress syndrome. The optimal strategy for prophylactic therapy, however, remains controversial. When administered as an endotracheal bolus immediately after delivery, surfactant mixes with the absorbing fetal lung fluid and may reach the alveoli before the onset of lung injury. This approach, however, causes a brief delay in the initiation of standard neonatal resuscitation, including positive pressure ventilation, and is associated with a risk for surfactant delivery into the right main stem bronchus or esophagus. As an alternative approach, surfactant prophylaxis may be administered in small aliquots soon after resuscitation and confirmation of endotracheal tube position. Although this strategy has substantial logistical advantages in clinical practice, its efficacy has not been established. OBJECTIVE: The purpose of this study was to determine whether the established benefits of the immediate bolus strategy for surfactant prophylaxis could still be achieved using a postventilatory aliquot strategy after initial standard resuscitation and stabilization. DESIGN: Multicenter randomized clinical trial with patients randomized before delivery to immediate bolus or postventilatory aliquot therapy. PARTICIPANTS: Inborn premature infants delivered to mothers at an estimated gestational age of 24[0/7] to 28[6/7] weeks. INTERVENTIONS: Those infants who were randomized to the immediate bolus strategy were intubated as rapidly as possible after birth, and a 3-mL intratracheal bolus of calf lung surfactant extract (Infasurf) was administered before the initiation of positive pressure ventilation. Those infants who were randomized to the postventilatory aliquot strategy received standard resuscitation measures with intubation by 5 minutes of age, if not required earlier. At 10 minutes after birth, 3 mL of surfactant was administered in 4 divided aliquots of 0.75 mL each. Patients in both groups were eligible to receive up to three additional doses of surfactant as rescue therapy in the neonatal intensive care unit, if needed. OUTCOME MEASURES: The primary outcome variable was survival to discharge to home. Secondary variables included neonatal complications and requirement for oxygen therapy at 36 weeks' postmenstrual age. RESULTS: Among three centers, 651 infants were enrolled and randomized before delivery. Survival to discharge to home was similar for the two strategies for surfactant therapy as prophylaxis: 76% for the immediate bolus group and 80% for the postventilatory aliquot group. In a secondary analysis, the rate of supplemental oxygen administration at 36 weeks' postmenstrual age was 18% for the immediate bolus group and 13% for the postventilatory aliquot group. CONCLUSIONS: Survival to discharge to home was similar with immediate bolus and postventilatory aliquot strategies for surfactant prophylaxis. Because of its logistical advantages in the delivery room and its beneficial effects on prolonged oxygen requirements, we recommend the postventilatory aliquot strategy for surfactant prophylaxis of premature infants delivered before 29 weeks' gestation.

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Acoustic features of expiratory cry vocalizations were studied in 125 pre-term infants prior to being discharged from a level-3 neonatal intensive care unit. The purpose was to describe various phonatory behaviors in infants in whom significant hearing loss could be ruled out. We also compared these results with normal-hearing full-term infants, and evaluated whether linkage exists among acoustic cry features and various anthropometric, diagnostic and treatment variables obtained throughout the peri- and neonatal periods. Our analysis revealed that cry duration was significantly related to total days receiving respiratory assistance. The occurrence of other complex spectral and temporal aspects of acoustic cry vocalizations including harmonic doubling and vibrato also increased in infants receiving some form of respiratory assistance. The presence of harmonic doubling also depended on weight and conceptional age at test. The discussion focuses on the implication of these relationships and directions for future research.

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The integrated perinatal information system in Albany Medical Center has two significant features: that of a flexible user-definable database and ease of networking both locally and regionally. The unified perinatal record is structured in Ansi standard MUMPS and resides on the College Vax 750. A special set of program tools ensures effective multi-split screen display, moving pointers, and corresponding multiple choice entries. Because it is self contained, it has the ability to create complex data structures without programming. A powerful math/statistical library has been incorporated. In house, the use of existing PABX wire allows for simultaneous voice/data traffic. Linkage to the regional system is made by modem connection. The system is compatible with the demands of both clinical and regional management.

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The differentiation of epithelial tissue in organ cultures of murine buccal mucosa, various human oral mucosa, and human newborn foreskin was found to be dependent on the calcium concentration of the culture media. In low calcium medium (less than or equal to 0.07 mM) epithelial differentiation was inhibited. The original stratifying layers separate and can be removed, producing a destratified explant. Histologically such an explant consists of a dorsal epithelial layer of basal keratinocytes resting on an intact basal lamina with subjacent stroma. At 0.01 mM calcium, the epithelial layer was one to two cells thick whereas at 0.07 mM it could be three or more layers in thickness with the most superficial cells being spread over the underlying cells. In addition to differentiation, keratinocyte migration over the sides of the explant (epiboly) and epithelial proliferation as determined by [3H]thymidine autoradiography were reduced by culture in low calcium medium. Redifferentiation occurs upon return to normal calcium levels (1.8 mM); addition of hydrocortisone to low calcium media was found to facilitate this redifferentiation.

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The early recognition of severe respiratory distress in the newborn allows for optimal care. The prompt identification of overwhelming respiratory failure may assist in the selection of candidates for new therapeutic techniques. We have evaluated, both retrospectively and prospectively, a simple scoring system for neonatal respiratory insufficiency. During the first 24 hr of life, serial inspired oxygen values (FiO2) are plotted with serial pH measurements against time on a graph. With pulmonary insufficiency, the lines cross. The severity of the insufficiency is quantified by integrating the area between the crossed lines. The 25 infants in our Regional Intensive Care Unit Nursery who died with respiratory distress syndrome (RDS) during 1976 were compared with surviving infants matched for gestational age, birth weight, and admission date; all patients received similar conventional management. The difference in the mean 24-hr cumulative scores between the two groups was significant (p < 0.01). Only 1 infant with a score over 40 U ultimately survived (96% specificity). From January 1978 through June 1979, data were graphed at the bedside on 100 neonates who required respiratory support, and analyzed without knowledge of the eventual outcome. Overall, the scoring system predicted the final outcome in 95% of the cases. False positive determinations were minimal, the system accurately selecting 86/87 ultimate survivors (98.8% specificity). These data suggest that this simple scoring system may prove useful in identifying infants with overwhelming respiratory distress. Such infants may be considered for specialized care or innovative yet unproven treatment modalities.

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A developmental questionnaire, encompassing the ages from 4 weeks to 36 months, has been devised that, when completed by parents, can be used to screen children as being developmentally normal, questionable, or abnormal. A total of 526 infants were screened by this questionnaire at 28 weeks of age and then examined at 40 weeks of age by a full Gesell Developmental and Neurologic Examination. Underscreening of those with major abnormalities was 2.6%, and of those with minor abnormalities, 10%. Overscreening was 6%. In view of the demonstrated high reliability and validity of the full Gesell Developmental and Neurologic Examination on which the questionnaire is based, the relatively small percentages of overscreening and underscreening make it the most accurate and useful screening questionnaire to date.

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Out of 262 premature newborn patients admitted with a diagnosis of respiratory distress, it was necessary to treat 70 with a ventilator. Of these 70, 25 eventually underwent tracheostomy. Indications for tracheostomy were that of an infant needing prolonged endotracheal intubation greater than one week. The procedure itself was easily performed and an overall complication rate of 7% was the result. Of the patients who underwent tracheostomy, 8% had significant complications. There was no death attributable to the treatment regime. We feel, therefore, that a combination approach starting with the endotracheal tube and progressing to tracheostomy when necessary, provided the best care for premature infants requiring intensive airway management.

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