Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial

Prematurity Clinical Trial

Official title:

Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645137
• Other study ID #: Multi-NE-O
• Status: Completed
• Phase: N/A
• First received: July 15, 2012
• Last updated: April 24, 2014
• Start date: July 2012
• Est. completion date: October 2013

Study information

• Verified date: April 2014
• Source: European Institute for Evidence Based Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. Results from previous studies documented the positive association between OMT and shorter period of hospitalisation as well as improvement of clinical conditions. The aim of this nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in premature infants across 3 neonatal intensive care units (NICU).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 29 Weeks to 37 Weeks

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

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

Locations

Country	Name	City	State
Italy	Macerata Hospital	Macerata	Marche
Italy	Monza Hospital	Monza	Lombardia
Italy	Pescara hospital	Pescara

Sponsors (2)

Lead Sponsor	Collaborator
European Institute for Evidence Based Osteopathic Medicine	Accademia Italiana Osteopatia Tradizionale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days of LOS		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	pre-post difference in weight gain		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	number of episodes of vomit		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	days to full enteral feeding		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	NICU costs		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	number of episodes of regurgitation		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	number of episodes of stooling		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No

External Links

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