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BACKGROUND:
Infants born before 29 weeks gestation in 2000 to 2003 were assessed at school age
by parental questionnaire, hospital chart review, and lung function tests. Children born
immediately before the introduction of routine palivizumab prophylaxis were compared with
age-matched children who received palivizumab prophylaxis during the rst respiratory
syncytial virus season.
METHODS:
Sixty-three children with a mean age 8.9 years were included: 30 had received
palivizumab and 33 had not (control subjects). The groups were similar in terms of
gestational age, birth weight, need for mechanical ventilation, and oxygen supplementation.
Fifty-three percent of the palivizumab group, compared with 39% of the control group, had
bronchopulmonary dysplasia (P .14). Wheezing occurred in the rst 2 years of life
in 27% of the palivizumab group and in 70% of control subjects (P .008); respective
hospitalization rates were 33% and 70% (P .001). At school age, rates of hyperresponsiveness (provocative concentration leading to a 20% fall in FEV1 < 1 mg/mL) were
33% and 48%, respectively (P .38). Spirometry, lung volumes, diffusion, and exhaled nitric
oxide were within normal limits, with no signicant differences between groups.
RESULTS:
KEY WORDS:
virus
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801
Results
Background Characteristics
118 suitable
35 excluded
Major congenital malformations (n = 5)
Neurological disorders (intraventricular
hemorrhage 3-4, post-hemorrhagic
hydrocephalus, periventricular leukomalacia)
(n = 30)
19 not located
99 contacted
36 not enrolled
Neurologically handicapped (cerebral palsy,
convulsions, pervasive developmental disorder) (n = 7)
Declined to participate (n = 29)
63 enrolled
Palivizumab group (n = 30)
Control group (n = 33)
Figure 1 Recruitment of subjects in mid-childhood.
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803
TABLE 1
Characteristics
Male sex
17 (56)
P Value
.62
26.5 (1.2)
26.7 (1.2)
889 (167)
944 (205)
.25
Surfactant treatment
23 (79)
28 (87)
.49
20 (71)
27 (82)
.37
7 (28)
7 (25)
.98
Postnatal steroids
Mechanical ventilation, d
.52
16 (0-58)
8 (0-81)
.17
3 (0-18)
3 (0-44)
.70
O2 support, d
54 (0-540)
33 (2-120)
.07
BPD
16 (53)
13 (39)
.14
9 (31)
4 (13)
.11
.47
CPAP, d
Data are given as No. (%) or median (range) unless otherwise indicated. BPD bronchopulmonary dysplasia; O2 oxygen; PCA postconceptional age.
Characteristics
Male sex
Age,a mean (SD), y
17 (56)
16 (48)
8.87 (0.6)
8.84 (0.8)
P Value
.62
.85
26.7 (5.7)
26.6 (6.1)
.92
128.6 (6.6)
129.8 (8.2)
.52
0.32 (1.04)
0.63 (1.36)
.32
Passive smoker
Family history of eczema or allergic rhinitis
Personal history of eczema or allergic rhinitis
Physician-diagnosed asthma
Wheezing episodes during last year
11 (37)
10 (30)
.42
9 (30)
14 (42)
.43
9 (30)
4 (12)
.12
10 (33)
6 (18)
.25
4 (13)
6 (18)
.73
Data are given as No. (%) unless otherwise indicated. SDS SD score.
a
At enrollment for pulmonary function testing.
TABLE 3
] Wheezing Episodes and Hospital Admissions Because of Respiratory Illness During the First 2 Years of
Life, by Palivizumab Prophylaxis
Outcome Parameters
P Value
8 (26.7)
23 (69.7)
.008a
10 (33.3)
23 (69.7)
.001a
10
32
.001a
RSV-positive admissions
2 (20.0)
19 (59.3)
.033a
5 (16.6)
21 (63.6)
.001a
4.6 (1.8)
.03b
6.4 (2.3)
Data are given as No. (%) unless otherwise indicated. RSV respiratory syncytial virus.
a
Fisher exact test.
b
Student t test.
Discussion
The current study investigated the impact of palivizumab
prophylaxis on the short- and long-term pulmonary
TABLE 4
Parameters
Control Group
P Value
30
89 (12)
32
89 (11)
.94
30
84 (13)
32
84 (11)
.87
30
8 (27)
32
6 (19)
.54
30
0.9 (0.1)
32
0.9 (0.1)
.75
26
0 (20 to 40)
30
.43
26
4 (15)
30
4 (13)
1.00
30
78 (27)
32
78 (27)
1.00
30
78 (28)
32
76 (29)
.79
26
15 (11 to 115)
30
22 (6 to 79)
.70
24
23
.72
24
15 (62)
23
15 (65)
.84
24
8 (33)
23
11 (48)
.38
FEF25%-75% forced expiratory ow at 25% to 75% of FVC; FEF50% forced expiratory ow at 50% of FVC; PC20 provocative concentration leading to a
20% fall in FEV1.
a
> 10% change in FEV1 after bronchodilation.
b
Positive methacholine test: PC20 < 4 mg/mL.
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TABLE 5
Parameters
Control Group
P Value
28
101 (14)
29
104 (13)
.30
28
128 (45)
29
145 (38)
.13
28
28
136 (32)
29
129 (22)
.36
17
93 (8)
26
90 (12)
.42
28
28
0.28 (0.08)
9.4 (2.0-33.2)
7 (25)
29
0.31 (0.06)
33
8.0 (3.0-64.7)
33
9 (27)
.10
.75
1.00
FENO fraction of exhaled nitric oxide; FRC functional residual capacity; KCO coefcient of diffusion; ppb parts per billion; RV residual volume;
TLC total lung capacity.
TABLE 6
] Pulmonary Function Tests at School Age in Patients With a Family History of Atopy, Eczema, or
Allergic Rhinitis
Palivizumab Group
Parameters
Control Group
P Value
10
94.7 (10.2)
15
91.9 (10.1)
.56
10
92.1 (10.9)
15
88.8 (8.4)
.68
14
.26
87.3 (30.2)
15
84.8 (30.4)
.87
8
10
24.6 (5 to 46)
14
.51
15
.15
13
.96
journal.publications.chestnet.org
Conclusions
Palivizumab prophylaxis was associated with reduced
hospital admissions and wheezing episodes during the
rst 2 years of life in children born with extreme
prematurity. However, it did not change the long-term
pulmonary outcome, including airway hyperreactivity, as
measured by pulmonary function testing at school age.
807
Acknowledgments
Author contributions: D. P. and H. B. had
full access to all the data in the study and take
responsibility for the integrity of the data and
the accuracy of the data analysis, including
and especially any adverse effects. D. P. and
H. B. contributed to the study conception and
design, patient recruitment, data collection,
analysis and interpretation of the data,
drafting of the initial manuscript, and
approved the nal manuscript as submitted.
E. K. contributed to patient recruitment, data
collection, analysis and interpretation of the
data, and revision of the manuscript, and
approved the nal manuscript as submitted;
E. B.-Y. contributed to data collection,
analysis and interpretation of the data, and
revision of the manuscript, and approved the
nal manuscript as submitted; G. K., H. M.,
M. M.-Z., P. S., G. S., and L. S. contributed
to interpretation of the data and revision
of the manuscript, and approved the nal
manuscript as submitted.
Financial/nonnancial disclosures: None
declared.
Role of sponsors: The sponsor had no role in
the design of the study, the collection and
analysis of the data, or the preparation of the
manuscript.
Other contributions: We thank the children
and their families for participating in a long
day of lung function testing. We thank Pearl
Lilos, BSc, for her dedicated statistical
analysis, Yelena Matyashuk and Nassrin
Gabarra for the meticulous performance of
the pulmonary function tests, and Ruthy
Erelboim for her secretarial assistance.
References
1. Hall CB, Weinberg GA, Iwane MK, et al.
The burden of respiratory syncytial virus
infection in young children. N Engl J Med.
2009;360(6):588-598.
2. Narang I, Baraldi E, Silverman M, Bush A.
Airway function measurements and the
long-term follow-up of survivors of
preterm birth with and without chronic
lung disease. Pediatr Pulmonol.
2006;41(6):497-508.
3. Brooks AM, Byrd RS, Weitzman M,
Auinger P, McBride JT. Impact of low
birth weight on early childhood asthma in
the United States. Arch Pediatr Adolesc
Med. 2001;155(3):401-406.
4. Kaplan E, Bar-Yishay E, Prais D, et al.
Encouraging pulmonary outcome for
surviving, neurologically intact, extremely
premature infants in the postsurfactant
era. Chest. 2012;142(3):725-733.
5. Stein RT, Sherrill D, Morgan WJ, et al.
Respiratory syncytial virus in early life and