Evidence map›Paper›PMID 25393080›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2015

Melatonin use for neuroprotection in perinatal asphyxia: a randomized controlled pilot study.

H Aly, H Elmahdy, M El-Dib, M Rowisha, M Awny, T El-Gohary, M Elbatch, M Hamisa, A-R El-Mashad

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03806816 (Use of Melatonin for Neuroprotection in Term Infants With Hypoxic-ischaemic Encephalopathy), which is not on this map. Cited by 106 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 8 pooled it
20.2field-weighted citation impact, top 1% 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.

NCT03806816 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Use of Melatonin for Neuroprotection in Term Infants With Hypoxic-ischaemic Encephalopathy

TypeinterventionalSponsorUniversity Hospital of FerraraRan2018 to 2022Enrolled100ConditionsHypoxic-Ischemic Encephalopathy, Cell Damage, Asphyxia PerinatalArmsMelatonin, PLACEBO group
3 · Its place in the literature

Who cites it

106 citing papers in PubMed, 8 syntheses or guidelines pooled it, 232 citations in OpenAlex.

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46 more citing papers are in PubMed but not listed here.

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

9 authors at 3 institutions in 2 countries.

H AlyDepartment of Newborn Services, George Washington University and Children's National Medical Center, Washington, DC, USA.
H ElmahdyDepartment of Neonatology, Tanta University, Tanta, Egypt.
M El-DibDepartment of Newborn Services, George Washington University and Children's National Medical Center, Washington, DC, USA.
M RowishaDepartment of Neonatology, Tanta University, Tanta, Egypt.
M AwnyDepartment of Neonatology, Tanta University, Tanta, Egypt.
T El-GoharyDepartment of Neurology, Tanta University, Tanta, Egypt.
M ElbatchDepartment of Biochemistry, Tanta University, Tanta, Egypt.
M HamisaDepartment of Radiology, Tanta University, Tanta, Egypt.
A-R El-MashadDepartment of Neonatology, Tanta University, Tanta, Egypt.
Tanta University · EGChildren's National · USGeorge Washington University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveMelatonin has been shown to be neuroprotective in animal models. The objective of this study is to examine the effect of melatonin on clinical, biochemical, neurophysiological and radiological outcomes of neonates with hypoxic-ischemic encephalopathy (HIE). STUDY

designWe conducted a prospective trial on 45 newborns, 30 with HIE and 15 healthy controls. HIE infants were randomized into: hypothermia group (N=15; received 72-h whole-body cooling) and melatonin/hypothermia group (N=15; received hypothermia and five daily enteral doses of melatonin 10 mg kg(-1)). Serum melatonin, plasma superoxide dismutase (SOD) and serum nitric oxide (NO) were measured at enrollment for all infants (N=45) and at 5 days for the HIE groups (N=30). In addition to electroencephalography (EEG) at enrollment, all surviving HIE infants were studied with brain magnetic resonance imaging (MRI) and repeated EEG at 2 weeks of life. Neurologic evaluations and Denver Developmental Screening Test II were performed at 6 months.

resultCompared with healthy neonates, the two HIE groups had increased melatonin, SOD and NO. At enrollment, the two HIE groups did not differ in clinical, laboratory or EEG findings. At 5 days, the melatonin/hypothermia group had greater increase in melatonin (P<0.001) and decline in NO (P<0.001), but less decline in SOD (P=0.004). The melatonin/hypothermia group had fewer seizures on follow-up EEG and less white matter abnormalities on MRI. At 6 months, the melatonin/hypothermia group had improved survival without neurological or developmental abnormalities (P<0.001).

conclusionEarly administration of melatonin to asphyxiated term neonates is feasible and may ameliorate brain injury.

Indexed as

Hypothermia, InducedAsphyxia NeonatorumElectroencephalographyFemaleHumansHypoxia-Ischemia, BrainInfant, NewbornMagnetic Resonance ImagingMaleMelatoninNeurologic ExaminationNeuroprotective AgentsNitric OxidePilot ProjectsProspective StudiesSuperoxide DismutaseMelatoninNeuroprotective AgentsNitric OxideSuperoxide Dismutase

Identifiers

PMID25393080
OpenAlexW2042016363

What OpenQuestion holds

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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.