Randomized Controlled Trials in Very Preterm Infants: Does
Inclusion in the Study Result in Any Long-Term Benefit?

J 2014

Randomized Controlled Trials in Very Preterm Infants: Does Inclusion in the Study Result in Any Long-Term Benefit?

RUEEGGER, CM, Andrea KRAUS, B KOLLER, G NATALUCCI, B LATAL et. al.

Základní údaje

Originální název

Randomized Controlled Trials in Very Preterm Infants: Does Inclusion in the Study Result in Any Long-Term Benefit?

Autoři

RUEEGGER, CM, Andrea KRAUS, B KOLLER, G NATALUCCI, B LATAL, E WALDESBUEHL, JC FAUCHERE, L HELD a HU BUCHER

Vydání

Neonatology, Basel, Karger, 2014, 1661-7800

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 2.649

DOI

http://dx.doi.org/10.1159/000362784

UT WoS

000340231900006

Klíčová slova anglicky

Preterm infants; Trial effect; Long-term outcome; Randomized controlled trial

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 12. 1. 2016 23:27, Mgr. Andrea Kraus, M.Sc., Ph.D.

Anotace

V originále

Background: Since the introduction of randomized controlled trials (RCT) in clinical research, there has been discussion of whether enrolled patients have worse or better outcomes than comparable non-participants. Objective: To investigate whether very preterm infants randomized to a placebo group in an RCT have equivalent neurodevelopmental outcomes to infants who were eligible but not randomized (eligible NR). Methods: In the course of an RCT investigating the neuroprotective effect of early high-dose erythropoietin on the neurodevelopment of very preterm infants, the outcome data of 72 infants randomized to placebo were retrospectively compared with those of 108 eligible NR infants. Our primary outcome measures were the mental (MDI) and psychomotor (PDI) developmental indices of the Bayley Scales of Infant Development II at 24 months of corrected age. The outcomes of the two groups were considered equivalent if the confidence intervals (CIs) of their mean differences fitted within our +/-5-point margin of equivalence. Results: Except for a higher socioeconomic status of the trial participants, both groups were balanced for most perinatal variables. The mean difference (90% CI) between the eligible NR and the placebo group was -2.1 (-6.1 and 1.9) points for the MDI and -0.8 (-4.2 and 2.5) points for the PDI. After adjusting for the socioeconomic status, maternal age and child age at follow-up, the mean difference for the MDI was -0.5 (-4.3 and 3.4) points. Conclusions: Our results indicate that the participation of very preterm infants in an RCT is associated with equivalent long-term outcomes compared to non-participating infants. (C) 2014 S. Karger AG, Basel

Citovat

RUEEGGER, CM, Andrea KRAUS, B KOLLER, G NATALUCCI, B LATAL, E WALDESBUEHL, JC FAUCHERE, L HELD a HU BUCHER. Randomized Controlled Trials in Very Preterm Infants: Does Inclusion in the Study Result in Any Long-Term Benefit? Neonatology. Basel: Karger, 2014, roč. 106, č. 2, s. 114-119. ISSN 1661-7800. Dostupné z: https://dx.doi.org/10.1159/000362784.

@article{1324044,
   author = {Rueegger, CM and Kraus, Andrea and Koller, B and Natalucci, G and Latal, B and Waldesbuehl, E and Fauchere, JC and Held, L and Bucher, HU},
   article_location = {Basel},
   article_number = {2},
   doi = {http://dx.doi.org/10.1159/000362784},
   keywords = {Preterm infants; Trial effect; Long-term outcome; Randomized controlled trial},
   language = {eng},
   issn = {1661-7800},
   journal = {Neonatology},
   title = {Randomized Controlled Trials in Very Preterm Infants: Does Inclusion in the Study Result in Any Long-Term Benefit?},
   volume = {106},
   year = {2014}
}

TY  - JOUR
ID  - 1324044
AU  - Rueegger, CM - Kraus, Andrea - Koller, B - Natalucci, G - Latal, B - Waldesbuehl, E - Fauchere, JC - Held, L - Bucher, HU
PY  - 2014
TI  - Randomized Controlled Trials in Very Preterm Infants: Does Inclusion in the Study Result in Any Long-Term Benefit?
JF  - Neonatology
VL  - 106
IS  - 2
SP  - 114-119
EP  - 114-119
PB  - Karger
SN  - 16617800
KW  - Preterm infants
KW  - Trial effect
KW  - Long-term outcome
KW  - Randomized controlled trial
N2  - Background: Since the introduction of randomized controlled trials (RCT) in clinical research, there has been discussion of whether enrolled patients have worse or better outcomes than comparable non-participants. Objective: To investigate whether very preterm infants randomized to a placebo group in an RCT have equivalent neurodevelopmental outcomes to infants who were eligible but not randomized (eligible NR). Methods: In the course of an RCT investigating the neuroprotective effect of early high-dose erythropoietin on the neurodevelopment of very preterm infants, the outcome data of 72 infants randomized to placebo were retrospectively compared with those of 108 eligible NR infants. Our primary outcome measures were the mental (MDI) and psychomotor (PDI) developmental indices of the Bayley Scales of Infant Development II at 24 months of corrected age. The outcomes of the two groups were considered equivalent if the confidence intervals (CIs) of their mean differences fitted within our +/-5-point margin of equivalence. Results: Except for a higher socioeconomic status of the trial participants, both groups were balanced for most perinatal variables. The mean difference (90% CI) between the eligible NR and the placebo group was -2.1 (-6.1 and 1.9) points for the MDI and -0.8 (-4.2 and 2.5) points for the PDI. After adjusting for the socioeconomic status, maternal age and child age at follow-up, the mean difference for the MDI was -0.5 (-4.3 and 3.4) points. Conclusions: Our results indicate that the participation of very preterm infants in an RCT is associated with equivalent long-term outcomes compared to non-participating infants. (C) 2014 S. Karger AG, Basel
ER  -

RUEEGGER, CM, Andrea KRAUS, B KOLLER, G NATALUCCI, B LATAL, E WALDESBUEHL, JC FAUCHERE, L HELD a HU BUCHER. Randomized Controlled Trials in Very Preterm Infants: Does Inclusion in the Study Result in Any Long-Term Benefit? \textit{Neonatology}. Basel: Karger, 2014, roč.~106, č.~2, s.~114-119. ISSN~1661-7800. Dostupné z: https://dx.doi.org/10.1159/000362784.

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