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

Not Applicable

Completed

• Conditions: Prematurity
• Interventions: Other: osteopathic manipulative treatment; Other: Usual care

• Registration Number: NCT01645137
• Lead Sponsor: European Institute for Evidence Based Osteopathic Medicine

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-15
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-20
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 690

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMT	osteopathic manipulative treatment	patients under usual medical care plus osteopathic treatment
control	Usual care	patients under usual medical care

Primary Outcome Measures

Name	Time	Method
Number of days of LOS	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcome Measures

Name	Time	Method
pre-post difference in weight gain	participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of vomit	participants will be followed for the duration of hospital stay, an expected average of 4 weeks
days to full enteral feeding	participants will be followed for the duration of hospital stay, an expected average of 4 weeks
NICU costs	participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of regurgitation	participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of stooling	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Trial Locations

Locations (3)

Macerata Hospital; 🇮🇹 Macerata, Marche, Italy

Monza Hospital; 🇮🇹 Monza, Lombardia, Italy

Pescara hospital; 🇮🇹 Pescara, Italy