Sequential analysis in neonatal research—systematic review

Lava, Sebastiano A. G.; Elie, Valéry; Ha, Phuong; Jacqz-Aigrain, Évelyne

doi:10.1007/s00431-018-3110-5

Cited by 3 publications

(2 citation statements)

References 41 publications

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“…Strengths of this study are the consistent blinding of all health professionals, parents, and statisticians involved in the trial and the adherence to a strict treatment protocol, including tapering medication. It is a rare example of a well-designed and well-performed clinical trial in the vulnerable population of newborns [1,15].…”

Section: Discussionmentioning

confidence: 99%

Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial

et al. 2019

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Three suitable compounds (morphine, chlorpromazine, and phenobarbital) to treat neonatal abstinence syndrome were compared in a prospective multicenter, double-blind trial. Neonates exposed to opioids in utero were randomly allocated to one of three treatment groups. When a predefined threshold of a modified Finnegan score was reached, treatment started and increased stepwise until symptoms were controlled. If symptoms could not be controlled with the predefined maximal dose of a single drug, a second drug was added. Among 143 infants recruited, 120 needed pharmacological treatment. Median length of treatment for morphine was 22 days (95% CI 18 to 33), for chlorpromazine 25 days (95% CI 21 to 34), and for phenobarbital 32 days (95% CI 27 to 38) (p = ns). In the morphine group, only 3% of infants (1/33) needed a second drug; in the chlorpromazine group, this proportion was 56% (24/43), and in the phenobarbital group 30% (13/44). Conclusion: None of the drugs tested for treating neonatal abstinence syndrome resulted in a significantly shorter treatment length than the others. As morphine alone was able to control symptoms in almost all infants, it may be preferred to the two other drugs but should still be tested against more potent opioids such as buprenorphine. Trial registration: At ClinicalTrials.gov NCT02810782 (registered retrospectively). What is Known: • Neonates exposed to opiates in utero and presenting with withdrawal symptoms should first be treated by non-pharmacological supportive measures. • In those who fail, drugs have to be given, but there is controversy which drug is best. What is New: • Among three candidates, morphine, chlorpromazine and phenobarbital, none resulted in significantly shorter treatment time. • As morphine alone was able to control symptoms in almost all infants, it may be preferred to the two other drugs.

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Section: Discussionmentioning

confidence: 99%

Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial

et al. 2019

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“…The sequential probability ratio test (SPRT) is the term that is used currently for this particular form of statistical analysis where the sample is not fixed in advance and stopped as soon as significant results are observed according to predefined rule. Sequential analysis has not been frequently used in many clinical trials where it should have been used [14].…”

Section: Introductionmentioning

confidence: 99%

The world is waiting, use sequential analysis and get us the evidence-based treatment we need for COVID-19

Taguri

Nasef

2020

Libyan Journal of Medicine

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Pharmaco-epidemiological research on herbal medicinal products in the paediatric population: data from the PhytoVIS study

et al. 2019

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In paediatrics, clinical study data are limited, especially on herbal medicinal products. To address this gap, 2063 datasets from the paediatric population were evaluated in the PhytoVIS data base. By screening for paediatric data, information on indication, gender, treatment, co-medication and tolerability were evaluated. The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety. The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events. The data shed light on a still neglected field of phyto-pharmacotherapy by giving information on the use of herbal medicines in an unselected cohort of paediatric patients. The results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.What is Known:• In Germany, about 85% of children receive one or more herbal medicinal products per year.• Despite international initiatives to promote clinical research in paediatrics, there are still many gaps of knowledge in the use of drugs in paediatrics.What is New:• The PhytoVIS project evaluated 2063 data sets from the paediatric population using herbal medicinal products.• The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety, and 84% of the patients rated the therapy as very good or good without adverse events.

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Sequential analysis in neonatal research—systematic review

Cited by 3 publications

References 41 publications

Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial

Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial

The world is waiting, use sequential analysis and get us the evidence-based treatment we need for COVID-19

Pharmaco-epidemiological research on herbal medicinal products in the paediatric population: data from the PhytoVIS study

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