Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05848895 · ClinicalTrials.gov registry record · NA
OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
A NA study of Plagiocephaly and Plagiocephaly, Nonsynostotic, sponsored by Osteopathy's Promise to Children.
- Recruiting
- Registry status
- NA
- Development phase
- 122
- Enrollment target
- 1
- Study location
NCT05848895: Recruiting NA study of Plagiocephaly and Plagiocephaly, Nonsynostotic, sponsored by Osteopathy's Promise to Children.
NCT05848895 is a NA study of Plagiocephaly and Plagiocephaly, Nonsynostotic that is actively recruiting participants, run by Osteopathy's Promise to Children. The registered enrollment target is 122 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05848895, a NA study of Plagiocephaly and Plagiocephaly, Nonsynostotic, is actively recruiting participants, sponsored by Osteopathy's Promise to Children.
- RECRUITING
- Registry status
- NA
- Development phase
- 122 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional/deformational plagiocephaly. The main hypothesis is that children who received OMT will show significantly improved anthropometric measures of cranial symmetry over those receiving the current pediatric standard of care of repositioning. This is a two-arm, randomized cross-over clinical trial. With parental consent, pediatric patients (infants \<4 months of age) will be organized into one of two groups: 1. Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry. 2. Those who receive standard care only with repositioning attention from the parents After 8-weeks of being in the first group, each participant will cross-over into the second group (OMT or repositioning) N = 122 subjects diagnosed with deformational plagiocephaly (DP) are to be recruited (to allow for natural attrition and loss to follow up) with the recruitment to continue until 61 patients have been placed in each of the two groups and will cross-over to the respective treatment group (OMT and standard of care repositioning therapy). Timeline: It is projected that to recruit and carry out the assessments and interventions (8-weeks of each group with 12-months of follow-up longitudinally), it will require two years (24-months) from the beginning of the study to completion.
Primary Outcome
Anthropometric measurement of cranial asymmetry
Conditions Studied
Interventions
- PROCEDURE Osteopathic Manipulative Treatment
- BEHAVIORAL Standard of Care Repositioning
Study Locations (1)
California
- Osteopathic Center San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2023-10-26 |
| Est. Completion | 2025-12 |
| Phase | NA |
What NCT05848895 shows while recruiting
NCT05848895 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 4 conditions, with Plagiocephaly appearing as the primary indexed condition, and to 2 interventions - of which Osteopathic Manipulative Treatment is the first listed.
NCT05848895 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05848895 about?
NCT05848895 is a clinical study titled "OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates". The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional/deformational plagiocephaly. The main hypothesis is that children who received OMT will show sign...
What is the current status of trial NCT05848895?
This trial is currently recruiting. It is a NA study. The enrollment target is 122 participants. The study started on 2023-10-26. Estimated completion is 2025-12.
What conditions does trial NCT05848895 study?
This clinical trial studies the following conditions: Plagiocephaly, Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Cranium; Deformity.
What interventions are being tested in trial NCT05848895?
The interventions under investigation include: Osteopathic Manipulative Treatment (PROCEDURE), Standard of Care Repositioning (BEHAVIORAL).
Who is sponsoring clinical trial NCT05848895?
This trial is sponsored by Osteopathy's Promise to Children, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05848895 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Plagiocephaly
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05848895's enrollment target sits among peer trials
122 762nd of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03363373 · 122 participants · Phase 2
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
- NCT03463954 · 122 participants · NA
Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
- NCT04503265 · 122 participants · Phase 1
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
- NCT04700527 · 122 participants · Phase 1
The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI