LONG TERM OUTCOMES AT (?2 YEARS)
OF ELBW INFANTS TREATED WITH EARLY LOW-DOSE HYDROCORTISONE (HC) TO
PREVENT BRONCHOPULMONARY DYSPLASIA (BPD).
KL Watterberg for the PROPHET study
group
Background:
360 mechanically ventilated ELBW infants
were enrolled in a randomized, multicenter study of the short and long term
effects of early HC prophylaxis of
early to prevent adrenal insufficiency
to prevent BPD. Short term
outcomes were reported in Pediatrics (114:1649, 2004). HC-treated infants exposed to chorioamnionitis
had significantly improved survival and survival without BPD.
Objective: To evaluate neurodevelopmental, growth and medical outcomes at 18 – 22 months corrected age in infants enrolled in the above study.
Methods: All
surviving infants ³ 18 months
corrected age (n=294____) were eligible for
evaluation by certified examiners masked to treatment assignment, including
standardized neurologic exam & Bayley Scales of Infant Development II
(BSID-II). Neurodevelopmental impairment
(NDI) = mental developmental index (MDI)
or physical developmental index (PDI)
<70, cerebral palsy (CP),
blindness or deafness. Treatment
group comparisons are based on multiple linear regression
models for continuous outcomes and multiple logistic
regression models for binary and
ordinal outcomes. All
analyses include adjustment for birth weight, gestational age,
prenatal steroid use, outborn status,
gender, motheraternal race (black
vs. all other), method of delivery,
and center where possible. Additionally,
gGrowth
outcomes are adjusted for corrected age by
computingusing
z-scores based on the CDC
2000 growth charts
for 2000. Statistical results from multiple regression
analysis…..
Results: 252
of 294___
survivors (86___%)
were seen at a mean ± SD of 20.0____
± 2.1___
months corrected age (mean ± SD, range 14.6__
- 28.0___). Maternal
education and household income were similar between groups. All results are
HC vs. placebo. There
were no significant differences
inResults were not different (HC vs. placebo) for
length (80.7___
± 3.5cm___
vs. 81.5 ___± 4.0cm)___,
weight (10.6
± 2.1kg vs. 10.9 ± 1.5kg),_______
or head circumference (47.1 ± 1.9cm
vs. 47.3 ± 1.8cm)_______.
or in Similar numbers were receiving
bronchodilators ___% vs. ___%. Fewer HC patients were
onreceiving bronchodilators (17%
vs. 23%) and
or inhaled/systemic steroids (19__
% vs. 25___%),
although not significantly different than placebo. Functional gross motor level
(normal 77% vs. 74%),
independent normal gaitwalking
(71% vs. 67%) and independent feeding
(73% vs. 65%) were all similar between groups
(________)..
|
|
Cerebral Palsy (CP) |
Bayley MDI |
Bayley PDI |
MDI <70 |
PDI<70 |
NDI |
|
HC-treated (n=126) |
|
80.4 ± 19.1 |
82.8 ± 19.4 |
32 (27%) |
31 (26%) |
48 (39%) |
|
Placebo (n=126) |
|
77.5 ± 19.3 |
83.9 ± 19.9 |
46 (37%) |
29 (23%) |
55 (44%) |
|
|
0.40 |
0.08 |
0.82 |
0.02* |
0.94 |
0.14 |
Conclusions:
Early, low dose HC treatment was not associated with an increase in
CP. Treated infants had indicators of
improved neurodevelopmental outcome. In
combination with the finding of improved survival without BPD in HC-treated
infants exposed to chorioamnionitis, Tthese
data support further, targeted studies of HC treatment for
of indicators of adrenal
insufficiency in ELBW infants.