Nasal Continuous Positive Airway Pressure and Early Surfactant Therapy for Respiratory Distress Syndrome in Newborns of Less Than 30 Weeks' Gestation

Article Figures & Data

Table 1.

Characteristics of Patients at Randomization

Characteristic	Early-treated Group (n = 33)	Late-treated Group (n = 27)	P
	Median (Range)
Birth weight (g)	950 (665–1600)	935 (618–1555)	.84
Gestational age (wk)	27 (25–29)	28 (25–29)	.54
Age at randomization (h)	4.1 (0.3–40.1)^*	4.5 (1.7–41.3)^*	.55
a/APo₂ at randomization	0.28 (0.22–0.38)^*	0.28 (0.08–0.77)^*	.69
TcPco₂ (mm Hg) at randomization	50 (34–103)	47 (30–74)	.69
	Number (%)
Male sex	17 (52)	18 (67)	.24
Born in treating hospital	30 (91)	24 (89)	.20
Cesarean section	25 (76)	17 (63)	.28
Theophylline	21 (64)	18 (67)	.81
Antenatal steroid	26 (79)	22 (81)	.80
Two doses	20 (61)	17 (63)	.85

↵* In both treatment groups the lowest age at entry was 2.0 hours and the range of a/APo₂ was 0.22 to 0.35 for infants fulfilling the entry criteria strictly (n = 54). One infant in each treatment group was randomized before 2 hours; the late-treated also had a/APo₂ <0.22. One infant treated early and 3 infants treated late had a/APo₂ >0.35.

Table 2.

Data on Study End Points

End point	Early Treatment	Late Treatment	P Value	Statistics
Mechanical ventilation and/or death <7 days, number (%)	7 (21)	17 (63)	.0013	Logistic regression
Mechanical ventilation and/or death before discharge, number (%)	9 (27)	19 (70)	.004	χ²
Mechanical ventilation before discharge, number (%)	8 (25)	17 (68)	.005	χ²
a/APo₂ after 6 hours, mean ± SD	0.48 ± 0.18	0.36 ± 0.18	.02	Multiple regression

Table 3.

Secondary Outcome Parameters Before Discharge (Total Study Population)

Table 4.

Secondary Outcome Parameters Before Discharge (Survivors)

	Curosurf		P
	Early Treatment (n = 30)	Late Treatment (n = 20)	P
	Number (%)
Bronchopulmonary dysplasia
Oxygen day 28	11 (37)	8 (40)	.81
Oxygen postconceptional week 36	1 (3)	1 (4)	.66
Intraventricular hemorrhage
Grades 1–2	5 (15)	2 (7)	.80
Grades 3–4	1 (3)	0	.84
Periventricular leucomalacia	0	0	1.00
Retinopathy of prematurity	3 (9)	2 (7)	.63
Cryotheraphy	1 (3)	1 (4)	.66
	Median (Range)
Oxygen treatment (day)	6.5 (0.3–69)	18.5 (0.5–64)	.54
Nasal CPAP (day)	38.5 (0.8–64)	39.0 (12–155)	.76
Mechanical ventilation^* (day)	2.5 (1.2–5.5)	2.1 (0.3–13.9)	.47