Evidence map›Paper›PMID 16407960›Full record

ArticleJournal of perinatology : official journal of the California Perinatal Association2006

A pilot trial testing the feasibility of administering D-penicillamine to extremely low birth weight neonates.

R D Christensen, S C Alder, S C Richards, J T Horn, D K Lambert, V L Baer

Open access · bronzeAbstract readComparative Study
PubMed Publisher
In one paragraph

Article in Journal of perinatology : official journal of the California Perinatal Association, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. The effects of D-penicillamine on a murine model of oxygen-induced retinopathy.Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus · 2011
    Article
  4. D-Penicillamine administration and the incidence of retinopathy of prematurity.Journal of perinatology : official journal of the California Perinatal Association · 2007
    Article
  5. An international replication, and the need for long term follow up studies.Archives of disease in childhood. Fetal and neonatal edition · 2006
    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

6 authors at 3 institutions in 1 country.

R D ChristensenDepartment of Women and Newborn, Intermountain Health Care and the McKay-Dee Hospital Center, Ogden, UT 84403, USA. rdchris4@ihc.com
S C Alder
S C Richards
J T Horn
D K Lambert
V L Baer
McKay Dee Hospital · USIntermountain Healthcare · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe enterally administered a 14-day course of 3-mercapto-D-valine (D-penicillamine) to five extremely low birth weight (ELBW) neonates, as a step toward assessing this therapy as a means of reducing the incidence or severity of retinopathy of prematurity (ROP).

methodsThe study drug (100 mg/ml) was given by nasogastric tube at a dose of 100 mg/k every 8 h for three days, and then 50 mg/k once per day for 11 additional days. Logbooks were maintained by the bedside nurses to record signs of possible immediate intolerance. Laboratory tests assessed hepatic, renal, and hematologic toxicity. ROP was scored according to the ICROP guidelines. Comparisons were with a cohort of 139 consecutive recent neonates of the same birth weight and gestational age range.

resultsFive neonates were enrolled in the study, and all received the full course of study drug as planned. Signs of immediate intolerance of the study drug were not observed in any. The study patients did not have a higher incidence, than that of the cohort group, in creatinine elevation, thrombocytopenia, neutropenia, hyperbilirubinemia, or abnormal liver function test. Four of the five had no ROP and one developed transient stage 1, compared with a 54% occurrence of ROP in the cohort.

conclusionsIt is feasible to enterally administer a 14-day course of 3-mercapto-D-valine to ELBW neonates and the suspension appears to be well tolerated. These results suggest that phase II safety and preliminary efficacy trials can be undertaken.

Indexed as

Infant, Very Low Birth WeightBirth WeightDose-Response Relationship, DrugDrug Administration ScheduleFeasibility StudiesFemaleFollow-Up StudiesGestational AgeHumansInfant, NewbornIntubation, GastrointestinalMaleMaximum Tolerated DosePenicillaminePilot ProjectsRetinopathy of PrematurityPenicillamine

Identifiers

PMID16407960
OpenAlexW2088648409

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.