Prematurity
Conditions
Keywords
prematurity, OMT, complementary and alternative medicine, neonates, length of stay
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).
Interventions
OTHERosteopathic manipulative treatment
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
OTHERUsual care
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Sponsors
Italian Academy of Traditional Osteopathy - AIOT
European Institute for Evidence Based Osteopathic Medicine
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days of LOS | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
| NICU costs | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
Countries
Italy
Outcome results
None listed