Evidence map›Paper›PMID 27612991›Full record

Trial reportPaediatric drugs2016

Doxapram Dosing for Apnea of Prematurity Based on Postmenstrual Age and Gender: A Randomized Controlled Trial.

E Greze, M Benard, I Hamon, C Casper, F E Haddad, M-J Boutroy, J-M Hascoët

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Paediatric drugs, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00389909 (Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–field-weighted citation impact, top 86% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00389909 phase4completednot on this map

Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants

TypeinterventionalSponsorJean Michel HascoetRan2006 to 2010Enrolled85ConditionsPremature Infants, ApneaArmsDoxapram
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Doxapram for the prevention and treatment of apnea in preterm infants.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

E GrezeNeonatology, Maternite Regionale, EA3450 Université de Lorraine, 10 Rue du Docteur Heydenreich, 54035, Nancy, France.
M BenardNeonatology, Children's Hospital, 330 Avenue de Grande-Bretagne, TSA 70034, 31059, Toulouse Cedex 9, France.
I HamonNeonatology, Maternite Regionale, EA3450 Université de Lorraine, 10 Rue du Docteur Heydenreich, 54035, Nancy, France.
C CasperNeonatology, Children's Hospital, 330 Avenue de Grande-Bretagne, TSA 70034, 31059, Toulouse Cedex 9, France.
F E HaddadNeonatology, Maternite Regionale, EA3450 Université de Lorraine, 10 Rue du Docteur Heydenreich, 54035, Nancy, France.
M-J BoutroyNeonatology, Maternite Regionale, EA3450 Université de Lorraine, 10 Rue du Docteur Heydenreich, 54035, Nancy, France.
J-M HascoëtNeonatology, Maternite Regionale, EA3450 Université de Lorraine, 10 Rue du Docteur Heydenreich, 54035, Nancy, France. j.hascoet@chru-nancy.fr.
Développement, Adaptation et HandicapCentre Hospitalier Universitaire de Toulouse · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDoxapram is used as a third-line treatment for apnea unresponsive to caffeine and continuous positive airway pressure (CPAP) in preterm infants.

objectivesThe objectives of this study were to compare the effects of dosing adjusted for gender and postmenstrual age (PMA) (GrA) versus infants' weight alone (GrW) on doxapram plasma levels, clinical efficacy, and side effects.

methodsThis was a randomized, double-blind study, including premature infants for whom optimized caffeine and CPAP therapy for apnea of prematurity had failed. Failure was defined as the persistence of more than one significant apnea per hour over an 8-h period. Plasma levels of doxapram and ketodoxapram were measured with high-performance liquid chromatography (HPLC) 48 h after the onset of treatment. Dosing aimed to maintain the combined doxapram and ketodoxapram plasma level in the therapeutic range of 1.5-4 mg/l. Infants were followed-up for 4 days after the onset of treatment.

resultsA total of 85 infants were included: 46 in GrW (27.7 ± 1.9 weeks' gestational age [GA]), 39 in GrA (27.9 ± 1.4 weeks' GA); available plasma levels showed that 25 of 40 in the GrW group and 27 of 37 in the GrA group had levels within the therapeutic range (p = 0.344). Of note, plasma level variance was significantly higher in GrW for doxapram + ketodoxapram (1.87 vs. 0.89; p = 0.028). Clinical efficacy was better in the GrA group, with a reduction from 32 to 3 of 38 (76 %) infants with significant apnea versus 30 to 5 of 45 (56 %) in the GrW group (p < 0.001). No adverse effects were observed during the study.

conclusionsTaking gender and PMA into account for doxapram dosing did not significantly increase the number of infants with a plasma level in the therapeutic range. However, it improved plasma level stability and clinical efficacy without adverse effects. ClinicalTrials.gov number: NCT00389909.

Indexed as

ApneaDouble-Blind MethodDoxapramFemaleHumansInfantInfant, NewbornInfant, PrematureInfant, Premature, DiseasesMaleProspective StudiesRespiratory System AgentsDoxapramRespiratory System Agents

Identifiers

PMID27612991
OpenAlexW2516659145

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.