Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prematurity
- Sponsor
- European Institute for Evidence Based Osteopathic Medicine
- Enrollment
- 690
- Locations
- 3
- Primary Endpoint
- Number of days of LOS
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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).
Investigators
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
Outcomes
Primary Outcomes
Number of days of 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(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)