Trial reportNeurotoxicology and teratology
Physiologic dysregulation in newborns with prenatal opioid exposure: Cardiac, respiratory and movement activity.
Trial report in Neurotoxicology and teratology. 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 3 papers.
What it found
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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.
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.
Physiology and Therapeutic Management of Neonatal Abstinence Syndrome
A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome: Therapeutic Efficacy and Neurobehavioral Outcomes
Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- Stochastic vibration and early weight growth in opioid-exposed newborns: a randomized trial.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- Modeling heart rate patterns to quantify neonatal opioid withdrawal syndrome.Pediatric research · 2026Article
- Actigraphy: An Adjunctive Method to Measure Irritability in Opioid-Exposed Newborns.Journal of nursing measurement · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundNewborns with prenatal opioid exposure (POE) are commonly diagnosed with neonatal abstinence/opioid-withdrawal syndromes due to characteristic symptoms and overt behaviors. However, little is known about the underlying physiology of opioid-exposed newborns.
objectiveCardiac, respiratory and movement activity were measured to identify physiologic dysregulation and quantify pathophysiologic instabilities of the central and autonomic nervous systems in POE newborns.
methodsIn this pilot study, 30 hospitalized POE newborns (>35 wks gestational age) participated in one of two study phases wherein physiologic activity was measured for an 8-10 h session. In Phase 1, 17 infants received usual treatment to provide a general assessment of physiologic activity. In Phase 2, 13 infants participated in an interventional study (NCT02768844) using a prototype mattress that delivered stochastic vibratory stimulation (SVS). Changes in physiologic activity were compared for device on (N) and off (F) for three interfeed periods (FNF or NFN).
resultsPhase 1 showed that although infants' heart rate was on average within normal newborn range (mean 137 bpm, SD 7), infants were tachycardic 16% of the study period and tachypneic (mean 74 breaths/min, SD 13) 62% of the period. Infants moved 33% of the period; 17% were durations >30 s. In Phase 2, heart rate, respiratory rate, movement duration and frequency were each reduced for SVS N compared to SVS F in the FNF protocol (P < 0.05).
conclusionFindings support that physiologic measures can identify dysregulation not captured with current withdrawal scoring assessments. Larger studies are warranted to assess if mattress SVS helps regulate pathophysiologic instabilities in infants with POE.
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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 OpenQuestion graph.