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Abstract
Objective
Our randomized, double-blind, placebo-controlled trial of transdermal nitroglycerin (GTN) for preterm labour demonstrated a significant reduction in neonatal morbidity and mortality. The objective of this study was to evaluate developmental performance in the children born to women who participated in the GTN trial after one year and two years of follow-up.
Methods
The Ages and Stages Questionnaires (ASQ) were used for the assessments, and five domains of child development (communication, gross motor skills, fine motor skills, problem-solving, and personal social skills) were evaluated. Supplementary analyses were performed after stratifying study subjects by gestational age at birth (<28, 28 to 32, 33 to 36, ≥ 37 weeks) or by defining study subjects as normal or abnormal using standard cut-offs.
Results
A total of 153 infants born to women who participated in the GTN trial were included in the initial follow-up. Among them, 111 (72.5%) children (55 in the GTN arm and 56 in the placebo arm) at 12 months of age and 83 (54.2%) children (42 in the GTN arm and 41 in the placebo arm) at 24 months of age completed the full ASQ. There were no differences in ASQ total score and five subscores between the GTN arm and the placebo arm at the one-year and two-year follow-up evaluations, in overall study subjects, or after stratifying study subjects by gestational age. A trend towards reduced abnormalities in the GTN arm at the two-year follow-up was observed, although there was no statistical significance.
Conclusion
Maternal GTN use for preterm labour had no impact on children’s long-term development, but larger studies are needed to confirm the preliminary findings of this study.
Résumé
Objectif
Notre essai comparatif contre placebo randomisé à double insu portant sur l’administration de nitroglycérine transdermique (GTN) pendant le travail préterme a démontré qu’une telle pratique entraînait une baisse significative de la morbidité et de la mortalité néonatales. Cette étude avait pour objectif d’évaluer le rendement développemental des enfants issus des participantes à l’essai GTN à la suite d’un an et de deux ans de suivi.
Méthodes
Les Ages and Stages Questionnaires (ASQ) ont été utilisés aux fins de l’évaluation et cinq domaines de développement infantile (communication, motricité globale, motricité fine, résolution de problème et aptitudes sociales personnelles) ont été évalués. Des analyses supplémentaires ont été menées à la suite de la stratification des sujets d’étude par âge gestationnel à la naissance (<28, de 28 à 32, de 33 à 36, ≥ 37 semaines) ou en définissant les sujets d’étude comme étant normaux ou anormaux au moyen de seuils standard.
Résultats
Au total, 153 nouveau-nés issus des participantes à l’essai GTN ont été inclus dans le suivi initial. Parmi eux, 111 (72,5 %) enfants (55 dans la branche GTN et 56 dans la branche placebo) à 12 mois et 83 (54,2 %) enfants (42 dans la branche GTN et 41 dans la branche placebo) à 24 mois ont rempli l’ensemble des ASQ. Aucune différence en matière de score total et de cinq sous-scores ASQ n’a été constatée entre la branche GTN et la branche placebo dans le cadre des évaluations à un an et à deux ans de suivi, et ce, chez l’ensemble des sujets d’étude ou à la suite de leur stratification par âge gestationnel. Une tendance vers une baisse du nombre d’anomalies au sein de la branche GTN à deux ans de suivi a été constatée; toutefois, cette baisse n’était pas significative sur le plan statistique.
Conclusion
L’administration maternelle de GTN pendant le travail préterme n’a exercé aucun effet sur le développement de l’enfant à long terme; cependant, la tenue d’études de plus grande envergure s’avère requise pour confirmer les résultats préliminaires de cette étude.
KeyWords
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Article info
Publication history
Accepted:
July 7,
2010
Received:
March 22,
2010
Footnotes
Competing Interests: None declared.
Identification
Copyright
© 2010 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.