Bmc Pediatr
-
Randomized Controlled Trial
Early signaling, referral, and treatment of adolescent chronic pain: a study protocol.
Chronic pain is prevalent among young people and negatively influences their quality of life. Furthermore, chronic pain in adolescence may persist into adulthood. Therefore, it is important early on to promote the self-management skills of adolescents with chronic pain by improving signaling, referral, and treatment of these youngsters. In this study protocol we describe the designs of two complementary studies: a signaling study and an intervention study. ⋯ If the Pain Barometer is proven to be feasible and Move It Now appears to be efficacious, a health care pathway can be created to provide the best tailored treatment promptly to adolescents with chronic pain. Move It Now can be easily implemented throughout the Netherlands, as the intervention is Internet based.
-
Randomized Controlled Trial
Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU.
The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU) can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. ⋯ The FNI is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as infant-mediated sensory experiences of the mother. Consequently, we are enlarging the testing of preterm infant neurodevelopment beyond that of previous research to include outcomes related to mother-infant interactions and mother-infant co-regulation. Our primary objective is to determine whether repeated engagement of the mother and her infant in the intervention's calming activities will improve the infant's developmental trajectory with respect to multiple outcomes. Our secondary objective is to assess the effectiveness of FNI in the physiological and psychological co-regulation of the mother and infant. We include aspects of neurodevelopment that have not been comprehensively measured in previous NICU interventions.
-
Randomized Controlled Trial Comparative Study
Infant flow biphasic nasal continuous positive airway pressure (BP- NCPAP) vs. infant flow NCPAP for the facilitation of extubation in infants' ≤ 1,250 grams: a randomized controlled trial.
The use of mechanical ventilation is associated with lung injury in preterm infants and therefore the goal is to avoid or minimize its use. To date there is very little consensus on what is considered the "best non-invasive ventilation mode" to be used post-extubation. The objective of this study was to compare the effectiveness of biphasic nasal continuous positive airway pressure (BP-NCPAP) vs. NCPAP in facilitating sustained extubation in infants ≤ 1,250 grams. ⋯ Biphasic NCPAP may be used to assist in weaning from mechanical ventilation. The effectiveness and safety of BP-NCPAP compared to NCPAP needs to be confirmed in a large multi-center trial as our study conclusions are limited by inadequate sample size. CLINICAL TRIALS REGISTRATION #: NCT00308789 SOURCE OF SUPPORT: Grant # 06-06, Physicians Services Incorporated Foundation, Toronto, Canada. Summit technologies Inc. provided additional NCPAP systems and an unrestricted educational grant.Abstract presented at The Society for Pediatric Research Meeting, Baltimore, USA, May 2nd-5th, 2009 and Canadian Paediatric Society Meeting, June 23rd-29th, Ottawa, 2009.
-
Randomized Controlled Trial
Baby Business: a randomised controlled trial of a universal parenting program that aims to prevent early infant sleep and cry problems and associated parental depression.
Infant crying and sleep problems (e.g. frequent night waking, difficulties settling to sleep) each affect up to 30% of infants and often co-exist. They are costly to manage and associated with adverse outcomes including postnatal depression symptoms, early weaning from breast milk, and later child behaviour problems. Preventing such problems could improve these adverse outcomes and reduce costs to families and the health care system. Anticipatory guidance-i.e. providing parents with information about normal infant sleep and cry patterns, ways to encourage self-settling in infants, and ways to develop feeding and settling routines before the onset of problems-could prevent such problems. This paper outlines the protocol for our study which aims to test an anticipatory guidance approach. ⋯ To our knowledge this is the first randomised controlled trial of a program which aims to prevent both infant sleeping and crying problems and associated postnatal depression symptoms. If effective, it could offer an important public health prevention approach to these common, distressing problems.
-
Randomized Controlled Trial Multicenter Study
Azithromycin for Indigenous children with bronchiectasis: study protocol for a multi-centre randomized controlled trial.
The prevalence of chronic suppurative lung disease (CSLD) and bronchiectasis unrelated to cystic fibrosis (CF) among Indigenous children in Australia, New Zealand and Alaska is very high. Antibiotics are a major component of treatment and are used both on a short or long-term basis. One aim of long-term or maintenance antibiotics is to reduce the frequency of acute pulmonary exacerbations and symptoms. However, there are few studies investigating the efficacy of long-term antibiotic use for CSLD and non-CF bronchiectasis among children. This study tests the hypothesis that azithromycin administered once a week as maintenance antibiotic treatment will reduce the rate of pulmonary exacerbations in Indigenous children with bronchiectasis. ⋯ Should this trial demonstrate that azithromycin is efficacious in reducing the number of pulmonary exacerbations, it will provide a much-needed rationale for the use of long-term antibiotics in the medical management of bronchiectasis in Indigenous children.