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Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

Effect of OMT on Length of Stay in a Population of Preterm Infants: RCT Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01544257
Enrollment
100
Registered
2012-03-05
Start date
2008-08-31
Completion date
2009-12-31
Last updated
2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

Keywords

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

Brief 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.

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.

Sponsors

European Institute for Evidence Based Osteopathic Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
29 Weeks to 37 Weeks
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

* 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.

Design outcomes

Primary

MeasureTime frame
evaluate the effectiveness of OMT in reducing LOSparticipants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary

MeasureTime frame
pre-post difference in weight gainparticipants will be followed for the duration of hospital stay, an expected average of 4 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026