Clinical trial NCT01645137: Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial
Official title: Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Keywords: prematurity
OMT
complementary and alternative medicine
neonates
length of stay
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
Collaborators: name: Italian Academy of Traditional Osteopathy - AIOT
First posted: 2012-07-20
Enrollment: 690
Sex: ALL
Minimum age (years): 29
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Number of days of LOS
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes:
measure: pre-post difference in weight gain
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: number of episodes of vomit
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: days to full enteral feeding
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: NICU costs
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: number of episodes of regurgitation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: number of episodes of stooling
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Monza Hospital
state: Lombardia
city: Macerata
country: Italy
facility: Macerata Hospital
state: Marche
city: Pescara
country: Italy
facility: Pescara hospital
Study officials:
References:
citation: Cerritelli F, Pizzolorusso G, Renzetti C, Cozzolino V, D'Orazio M, Lupacchini M, Marinelli B, Accorsi A, Lucci C, Lancellotti J, Ballabio S, Castelli C, Molteni D, Besana R, Tubaldi L, Perri FP, Fusilli P, D'Incecco C, Barlafante G. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms. PLoS One. 2015 May 14;10(5):e0127370. doi: 10.1371/journal.pone.0127370. eCollection 2015.
citation: Cerritelli F, Pizzolorusso G, Renzetti C, D'Incecco C, Fusilli P, Perri PF, Tubaldi L, Barlafante G. Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre randomised clinical trial. BMJ Open. 2013 Feb 20;3(2):e002187. doi: 10.1136/bmjopen-2012-002187. Print 2013.