School-age follow-up of prophylactic versus rescue surfactant trial: pulmonary, neurodevelopmental, and educational outcomes.
BACKGROUND
Exogenous surfactant replacement has improved survival and reduced pulmonary complications of prematurity. Improved early outcomes for infants of <30 weeks' gestation treated with a strategy of prophylactic versus rescue surfactant, if needed, were demonstrated in a multicenter, randomized trial conducted between 1985 and 1988. We reevaluated a subset of survivors from this trial to determine the pulmonary and neurodevelopmental outcomes at school age.


METHODS
At 4.5 to 8 years of age, all survivors from one of the three centers were located, and 96% were evaluated. The original randomization included stratification by center and followed an intention-to-treat methodology in assessing the efficacy of prophylactic versus rescue treatment with surfactant. The follow-up test battery included a health-assessment questionnaire, spirometry, 88% saturation test, neurologic examination, and the McCarthy Scales of Children's Abilities (MSCA) and the Conners' Parent Rating Scale-48. Educational achievement was determined by school class placement and teachers' reports of achievement.


RESULTS
Of the 192 children originally enrolled, 154 survived. Evaluations were performed on 148 of these infants. An abnormal pulmonary history was found in 45 (30%) of the children: 16 (22%) in the prophylactic group and 29 (39%) in the rescue group. Formal pulmonary function was evaluated in 81 children; 29 (78%) in the prophylactic group and 33 (75%) in the rescue group were considered abnormal. No significant differences were found between the two groups on either cognitive or motor subscales of the MSCA, the Conners' Parent Rating Scale-48, the neurologic examination, the education services received in school, or the teacher ratings of below-average academic performance. Intelligence scores measured on the MSCA were low-normal for both groups. Some level of educational assistance was being provided to 72 (49%) of the cohort studied, and both groups had below average educational performance and increased needs for educational assistance.


CONCLUSIONS
Prophylactic surfactant administration to infants of <30 weeks' gestation was associated with fewer long-term clinical pulmonary complications than assignment to rescue administration. Formal pulmonary testing at school age did not reveal significant differences between treatment groups in those infants who could be tested. There also were no group differences found on neurologic, cognitive, behavioral, or educational assessments at school age.
Sinkin
R A
RA
Departments of Pediatrics and Biostatistics, Children's Hospital at Strong, Rochester, NY 14642, USA.
Kramer
B M
BM
Merzbach
J L
JL
Myers
G J
GJ
Brooks
J G
JG
Palumbo
D R
DR
Cox
C
C
Kendig
J W
JW
Mercier
C E
CE
Phelps
D L
DL
D002648:Child; D002657:Child Development / Q000187:drug effects; D002675:Child, Preschool; D004519:Education, Special; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007360:Intelligence / Q000187:drug effects; D008171:Lung Diseases / Q000453:epidemiology / Q000517:prevention & control* / Q000628:therapy; D008297:Male; D010102:Oxygen Inhalation Therapy; D011581:Psychological Tests; D011663:Pulmonary Surfactants / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy* / Q000517:prevention & control; D015656:Respiratory Mechanics; D013147:Spirometry
D011663:Pulmonary Surfactants