PMID- 9787686
OWN - NLM
STAT- MEDLINE
DCOM- 19981125
LR  - 20220311
IS  - 0022-3476 (Print)
IS  - 0022-3476 (Linking)
VI  - 133
IP  - 4
DP  - 1998 Oct
TI  - Respiratory syncytial virus immune globulin for prophylaxis against respiratory 
      syncytial virus disease in infants and children with congenital heart disease. 
      The Cardiac Study Group.
PG  - 492-9
AB  - OBJECTIVE: To examine the effectiveness of respiratory syncytial virus immune 
      globulin administered intravenously (RSV-IGIV) in reducing hospitalization for 
      treatment of RSV in children with congenital heart disease (CHD). METHODS: 
      Children younger than 4 years of age were randomly assigned to a treatment group 
      receiving RSV-IGIV, 750 mg/kg, monthly or to a control group not receiving 
      infusions. Surveillance for respiratory tract infections was carried out and 
      management decisions were made by physicians blinded to treatment group. RESULTS: 
      Hospitalization for treatment of an RSV infection occurred in 32 of 214 (15%) of 
      control children and 21 of 202 (10%) of the children receiving RSV-IGIV, a 31% 
      reduction (P = .16). However, in infants younger than 6 months of age at study 
      entry, 20 of 82 (24%) in the control group and 10 of 96 (10%) in the RSV-IGIV 
      group had RSV hospitalizations (58% reduction, P = .01). The incidence of 
      hospitalization for any respiratory tract symptomatology was lower in the 
      RSV-IGIV group (34 of 202, 17%) than in the control group (57 of 214, 27%; P = 
      .02). There was a significantly higher frequency of unanticipated cyanotic 
      episodes and of poor outcomes after surgery among children with cyanotic CHD in 
      the RSV-IGIV group (22 of 78, 28%) than in the control group (4 of 47, 8.5%; P = 
      .009). CONCLUSION: RSV-IGIV should not be used for prophylaxis of RSV disease in 
      children with cyanotic CHD. RSV-IGIV did not reduce RSV hospitalization in all 
      children with CHD, but it was effective in preventing RSV hospitalization in 
      infants younger than 6 months of age. Further studies in these children are 
      indicated.
FAU - Simoes, E A
AU  - Simoes EA
AD  - University of Colorado, Denver, USA.
FAU - Sondheimer, H M
AU  - Sondheimer HM
FAU - Top, F H Jr
AU  - Top FH Jr
FAU - Meissner, H C
AU  - Meissner HC
FAU - Welliver, R C
AU  - Welliver RC
FAU - Kramer, A A
AU  - Kramer AA
FAU - Groothuis, J R
AU  - Groothuis JR
LA  - eng
GR  - 5N01RR00069/RR/NCRR NIH HHS/United States
GR  - RR-69/RR/NCRR NIH HHS/United States
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Pediatr
JT  - The Journal of pediatrics
JID - 0375410
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (respiratory syncytial virus immune globulin intravenous)
SB  - IM
MH  - Age Factors
MH  - Child, Preschool
MH  - Cyanosis/complications
MH  - Heart Defects, Congenital/*complications
MH  - Humans
MH  - Immunoglobulins, Intravenous/*therapeutic use
MH  - Infant
MH  - Intensive Care Units, Pediatric
MH  - Prospective Studies
MH  - Respiratory Syncytial Virus Infections/*complications/*prevention & 
      control/rehabilitation
MH  - *Respiratory Syncytial Viruses
MH  - Single-Blind Method
EDAT- 1998/10/27 03:02
MHDA- 2001/03/28 10:01
CRDT- 1998/10/27 03:02
PHST- 1998/10/27 03:02 [pubmed]
PHST- 2001/03/28 10:01 [medline]
PHST- 1998/10/27 03:02 [entrez]
AID - S0022347698004466 [pii]
AID - 10.1016/s0022-3476(98)70056-3 [doi]
PST - ppublish
SO  - J Pediatr. 1998 Oct;133(4):492-9. doi: 10.1016/s0022-3476(98)70056-3.