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

NCT01645137 | Completed

• 1 other identifier: Multi-NE-O
• Study Type: interventional
• Target: 690
• Locations: 1 country
• Sites: 3

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).

Conditions

Prematurity

Keywords

prematurity; OMT; complementary and alternative medicine; neonates; length of stay

Outcome Measures

Primary Outcomes (1)

• Number of days of LOS

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

OMT

EXPERIMENTAL

patients under usual medical care plus osteopathic treatment

Other: osteopathic manipulative treatment

control

OTHER

patients under usual medical care

Other: Usual care

Interventions

osteopathic manipulative treatment OTHER

Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.

OMT

Usual care OTHER

Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

control

Eligibility Criteria

• Age: 29 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• preterm infants born at age between 29 and 37 weeks
• osteopathic treatment performed \< 14 days after birth
• preterms born in the same hospital

You may not qualify if:

• 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)

Sponsors & Collaborators

• European Institute for Evidence Based Osteopathic Medicine: lead
• Italian Academy of Traditional Osteopathy - AIOT: collaborator

Study Sites (3)

Monza Hospital

Monza, Lombardy, 20052, Italy

Location

Macerata Hospital

Macerata, The Marches, 62100, Italy

Location

Pescara hospital

Pescara, 65121, Italy

Location

Related Publications (2)

• 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.

  PMID: 25974071 DERIVED

• 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.

  PMID: 23430598 DERIVED

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Premature Birth

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2012
• First Posted: July 20, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

IT (3)