Early Exposure to OMT Prevents Long LOS

NCT ID: NCT01784835

Last Updated: 2013-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-07-31

Brief Summary

The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants

Conditions

Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control

patients under standard medical care

Group Type: OTHER

Usual care

Intervention Type: OTHER

Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

OMT

patients under usual medical care plus osteopathic treatment

Group Type: EXPERIMENTAL

osteopathic manipulative treatment

Intervention Type: OTHER

Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.

Interventions

osteopathic manipulative treatment

Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.

Intervention Type: OTHER

Usual care

Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

Intervention Type: OTHER

Eligibility Criteria

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 weeks
• Gestational age > 37 weeks
• First OMT performed after 14 days from birth
• genetic disorders
• congenital disorders
• cardiovascular abnormalities
• proven or suspected necrotized enterocolitis with or without gastrointestinal perforation proven or suspected abdominal obstruction
• pre/post surgery patients
• pneumoperitoneum
• atelectasis
• Newborn from an HIV seropositive/drug addicted mother
• respiratory disorders
• transferred to/from other hospital
• admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Institute for Evidence Based Osteopathic Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Macerata Hospital

Macerata, Macerata, Italy

Countries

Italy

References

Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15.

Reference Type: BACKGROUND

PMID: 21711535 (View on PubMed)

Other Identifiers

NEO-02

Identifier Type: -

Identifier Source: org_study_id