Evidence map›Paper›PMID 33070152›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2021

"Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial."

Mohammad Hosny Awad, Sahar Amer, Mona Hafez, Islam Nour, AbdElaziz Shabaan

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.3field-weighted citation impact, top 12% 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.

NCT04418180 nacompletednot on this map

Fenofibrate as an Adjuvant to Phototherapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants: A Randomized Control Trial.

TypeinterventionalSponsorMansoura UniversityRan2016ConditionsNeonatal JaundiceArmsFenofibrate, Placebo
NCT06346743 phase2 / phase3unknown statusnot on this mapstarted 2024, after this paper: background citation

Comparison of Effects of Fenofibrate Adjuvant Therapy Versus Conventional Phototherapy in Treatment of Neonatal Exaggerated Hyperbilirubinemia.

TypeinterventionalSponsorMuhammad ZarkRan2024 to 2024Enrolled156ConditionsPhysiological Neonatal Jaundice, Physiological HyperbilirubinaemiaArmsFenofibrate, Phototherapy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
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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

5 authors at 1 institution in 1 country.

Mohammad Hosny AwadDepartment of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt. mo7amed_hosny@hotmail.com.ORCID http://orcid.org/0000-0002-9177-6554
Sahar AmerDepartment of pediatrics, Insurance Hospital, Ministry of health, Mansoura, Egypt.
Mona HafezDepartment of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt.
Islam NourDepartment of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt.ORCID http://orcid.org/0000-0002-9033-6290
AbdElaziz ShabaanDepartment of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt.ORCID http://orcid.org/0000-0002-4477-3297
Children's Hospital Mansoura University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite widespread phototherapy usage, many new-born infants remain in need of other invasive lines of therapy, such as intravenous immunoglobulins and exchange transfusions.

objectiveAssessment of the efficacy and the safety of adding fenofibrate to phototherapy for the treatment of pathological jaundice in full-term infants. DESIGN/

methodsWe conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU at Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg/kg/day for 1 day or 2 days or placebo in addition to phototherapy. The primary outcome was total serum bilirubin values after 12, 24, 36, 48, and 72 h from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate. This study was registered at www.clinicaltrials.gov (NCT04418180).

resultsA total of 180 full-term infants were included, 60 in each group. Infants in group I and II showed significant reduction of bilirubin levels at 36, 48, and 72 h from intervention compared to group III, respectively. Fenofibrate administration was associated with significantly shorter duration of phototherapy, shorter hospital stay, and higher frequency of exclusive breast-feeding compared to phototherapy alone. CONCLUSION(S): Fenofibrate as an adjuvant to phototherapy in term neonate with pathological jaundice is well tolerated and associated with significant reduction of serum bilirubin levels, a shorter duration of phototherapy, shorter hospital stay and higher frequency of exclusive breast-feeding, without significant adverse effects in either the single or double dosage.

Indexed as

FenofibrateHyperbilirubinemia, NeonatalChildDouble-Blind MethodExchange Transfusion, Whole BloodFemaleHumansHyperbilirubinemiaInfantInfant, NewbornPhototherapyTreatment OutcomeFenofibrate

Identifiers

PMID33070152
OpenAlexW3093233269

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.