CompletedNCT01544257Updated Mar 5, 2012

Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

A Phase 4 interventional study of osteopathic manipulative treatment and Usual care in Prematurity, sponsored by European Institute for Evidence Based Osteopathic Medicine. Completed at 1 site in Italy. Open to participants aged 29 Weeks to 37 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-05.

Sponsored by European Institute for Evidence Based Osteopathic Medicine · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 29 Weeks to 37 Weeks
Sex: All

Study summary

The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of the present study is to show the effect of OMT on LOS in a sample of premature infants.

Conditions studied

Prematurity

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Premature Birth 2,554

Keywords

Osteopathic manipulative treatment
alternative medicine
complementary medicine
neonatology
neonatal care
prematurity
allied health care

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 100 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

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Lead sponsor

European Institute for Evidence Based Osteopathic Medicine is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 29 Weeks to 37 Weeks
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

preterm infants born at age between 29 and 37 weeks
osteopathic treatment performed \< 14 days after birth
preterms born in the same hospital

Exclusion criteria

Exclusion Criteria:

gestational age \< 29, > 37 weeks;
osteopathic treatment performed > 14 days after birth;
newborn transferred to/from other hospital;
newborn from to HIV seropositive and/or drug addict mother;
newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 100 participants (actual)

Study arms

Experimental
OMT
patients under standard medical care plus OMT.
Other: osteopathic manipulative treatment
No intervention
Control
patients under standard medical care plus only osteopathic evaluation
Procedure: Usual care

Interventions

Otherosteopathic manipulative treatment
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
ProcedureUsual care
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

What researchers measure

Primary outcomes

evaluate the effectiveness of OMT in reducing LOS
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary outcomes

pre-post difference in weight gain
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study locations

1 site

Francesco Cerritelli
Pescara, 65124, Italy

References and documents

Publications

Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65. PubMed 23622070 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01544257
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Responsible party: Sponsor
First posted: Mar 5, 2012
Start date: Aug 2008
Primary completion: Dec 2009
Completion: Dec 2009
Last update: Mar 5, 2012

Study contacts

Francesco Cerritelli, DO, MS

study chair · European Institute for Evidence Based Osteopathic Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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