Evidence map›Paper›PMID 41704598›Full record

ArticleFrontiers in pediatrics2026

Impact of intrahepatic cholestasis of pregnancy on neonatal respiratory outcomes (CHOLE-RESP): protocol for a prospective cohort study.

Lucia Elena Niculae, Alexandru Stefan Niculae, Raluca Tocariu, Aida Petca

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06679972 (Intrahepatic Cholestasis of Pregnancy and the Respiratory Challenges of Bile Acids Pneumonia in Neonates), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT06679972 enrolling by invitationnot on this map

Intrahepatic Cholestasis of Pregnancy and the Respiratory Challenges of Bile Acids Pneumonia in Neonates (The CHOLE-RESP Trial)

Typeobservational_patient_registrySponsorCarol Davila University of Medicine and PharmacyRan2024 to 2028Enrolled120ConditionsIntrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

4 authors.

Lucia Elena NiculaeDepartment of Obstetrics and Gynecology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania.
Alexandru Stefan NiculaeDepartment of Pediatric Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania.
Raluca TocariuDepartment of Obstetrics and Gynecology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania.
Aida PetcaDepartment of Obstetrics and Gynecology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Intrahepatic cholestasis of pregnancy (ICP) is the most common liver disorder unique to pregnancy, associated with elevated maternal bile acid concentrations and adverse perinatal outcomes. Methods: This is a prospective cohort study conducted in a level III neonatal unit in Bucharest, Romania. Neonates born to mothers with ICP (serum bile acids ≥10 μmol/L within seven days before delivery) will be enrolled alongside gestational age, sex and birthweight-matched controls. Serum samples will be collected at 24 h, 48-72 h and on day 7 of life. Quantitative ELISA kits will be used to assess serum biomarkers associated with surfactant dysfunction and lung injury. Perinatal and clinical outcomes will be recorded systematically. Results: The primary aims are to compare the incidence of respiratory distress syndrome (RDS), the need for surfactant administration and serum biomarker profiles between ICP-exposed and unexposed neonates. Secondary aims include evaluating respiratory support requirements, neonatal morbidity and mortality across groups. Conclusions: We expect that neonates exposed to maternal cholestasis will have a higher incidence of RDS, increased surfactant need, and biomarker alterations consistent with pulmonary compromise. This study may improve understanding of bile acid-related lung injury and inform early risk stratification strategies in affected newborns. (NCT06679972).

Indexed as

biomarkerscohort studiesintrahepatic cholestasislivermorbiditypregnancy complicationsprospective studiespulmonary surfactants

Identifiers

PMID41704598
PMCPMC12907319

What Socratic holds

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LicenceCC BY
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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 Socratic graph.