Design and conduct of a large obstetric or neonatal randomized controlled trial

Tarnow‐Mordi, William; Cruz, Melinda; Morris, Jonathan M.

doi:10.1016/j.siny.2015.10.001

Cited by 17 publications

(7 citation statements)

References 124 publications

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“…60,61 Multi-site clinical trials are one solution to this problem. 62 Comparative effectiveness research studies, in which common data elements from many clinical sites are systematically collected, are appearing in CP research and could offer another solution to the methodological challenge of small sample sizes. 63 Other important sample characteristics, such as the ages when infants were recruited, ages at final assessment, and accurate identification of infants with CP, varied considerably among the studies, which made it challenging to compare results across studies.…”

Section: Sample Characteristicsmentioning

confidence: 99%

Effectiveness of motor interventions in infants with cerebral palsy: a systematic review

Morgan

Darrah

Gordon

et al. 2016

Develop Med Child Neuro

286

206

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Aim To systematically review the evidence on the effectiveness of motor interventions for infants from birth to 2 years with a diagnosis of cerebral palsy or at high risk of it. Method Relevant literature was identified by searching journal article databases (PubMed, Embase, CINAHL, Cochrane, Web of Knowledge, and PEDro). Selection criteria included infants between the ages of birth and 2 years diagnosed with, or at risk of, cerebral palsy who received early motor intervention. Results Thirty‐four studies met the inclusion criteria, including 10 randomized controlled trials. Studies varied in quality, interventions, and participant inclusion criteria. Neurodevelopmental therapy was the most common intervention investigated either as the experimental or control assignment. The two interventions that had a moderate to large effect on motor outcomes (Cohen's effect size>0.7) had the common themes of child‐initiated movement, environment modification/enrichment, and task‐specific training. Interpretation The published evidence for early motor intervention is limited by the lack of high‐quality trials. There is some promising evidence that early intervention incorporating child‐initiated movement (based on motor‐learning principles and task specificity), parental education, and environment modification have a positive effect on motor development. Further research is crucial.

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Section: Sample Characteristicsmentioning

confidence: 99%

Effectiveness of motor interventions in infants with cerebral palsy: a systematic review

Morgan

Darrah

Gordon

et al. 2016

Develop Med Child Neuro

286

206

View full text Add to dashboard Cite

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“…The recent call for large cluster or cross-over cluster randomized trials in which the NICU is randomized rather than the infant is particularly applicable to probiotics and NEC. 103 …”

Section: Mechanisms Of Actionmentioning

confidence: 99%

Impact of probiotics on necrotizing enterocolitis

Underwood

2017

Seminars in Perinatology

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A large number of randomized placebo-controlled clinical trials and cohort studies have demonstrated a decrease in the incidence of necrotizing enterocolitis with administration of probiotic microbes. These studies have prompted many neonatologists to adopt routine prophylactic administration of probiotics while others await more definitive studies and/or probiotic products with demonstrated purity and stable numbers of live organisms. Cross-contamination and inadequate sample size limit the value of further traditional placebo-controlled randomized controlled trials. Key areas for future research include mechanisms of protection, optimum probiotic species or strains (or combinations thereof) and duration of treatment, interactions between diet and the administered probiotic, and the influence of genetic polymorphisms in the mother and infant on probiotic response. Next generation probiotics selected based on bacterial genetics rather than ease of production and large cluster-randomized clinical trials hold great promise for NEC prevention.

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“…Because of ethical concerns, safety data for analgesic use in pregnancy is largely limited to animal studies or observational studies in humans, and thus may be confounded by selection bias, and exposure or outcome misclassification . Many obstetric studies also have methodological issues, such as low recruitment rates and inadequate sample sizes, which may limit their feasibility and external validity . Safety data must therefore be interpreted carefully, which can be challenging for the busy clinician.…”

Section: Introductionmentioning

confidence: 99%

Medication Use and Pain Management in Pregnancy: A Critical Review

Black¹,

Khor

Kennedy

et al. 2019

Pain Practice

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Background Pain during pregnancy is common, and its management is complex. Certain analgesics may increase the risk for adverse fetal and pregnancy outcomes, while poorly managed pain can result in adverse maternal outcomes such as depression and hypertension. Guidelines to assist clinicians in assessing risks and benefits of exposure to analgesics for the mother and unborn infant are lacking, necessitating evidence‐based recommendations for managing pain in pregnancy. Methods A comprehensive literature search was conducted to assess pregnancy safety data for pharmacological and nonpharmacological pain management methods. Relevant clinical trials and observational studies were identified using multiple medical databases, and included studies were evaluated for quality and possible biases. Results Paracetamol and nonsteroidal anti‐inflammatory drugs (NSAIDs) are appropriate for mild to moderate pain, but NSAIDs should be avoided in the third trimester due to established risks. Short courses of weaker opioids are generally safe in pregnancy, although neonatal abstinence syndrome must be monitored following third trimester exposure. Limited safety data for pregabalin and gabapentin indicate that these are unlikely to be major teratogens, and tricyclic antidepressants and serotonin‐norepinephrine reuptake inhibitors have limited but overall reassuring safety data. Many of the included studies were limited by methodological issues. Conclusions Findings from this review can guide clinicians in their decision to prescribe analgesics for pregnant women. Treatment should be tailored to the lowest therapeutic dose and shortest possible duration, and management should involve a discussion of risks and benefits and monitoring for response. Further research is required to better understand the safety profile of various analgesics in pregnancy.

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Design and conduct of a large obstetric or neonatal randomized controlled trial

Cited by 17 publications

References 124 publications

Effectiveness of motor interventions in infants with cerebral palsy: a systematic review

Effectiveness of motor interventions in infants with cerebral palsy: a systematic review

Impact of probiotics on necrotizing enterocolitis

Medication Use and Pain Management in Pregnancy: A Critical Review

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