Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

NCT01544257 | Completed Phase 4 DMC

• 1 other identifier: NEO-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of the present study is to show the effect of OMT on LOS in a sample of premature infants.

Conditions

Prematurity

Keywords

Osteopathic manipulative treatment; alternative medicine; complementary medicine; neonatology; neonatal care; prematurity; allied health care

Outcome Measures

Primary Outcomes (1)

• evaluate the effectiveness of OMT in reducing LOS

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

Secondary Outcomes (1)

• pre-post difference in weight gain

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

Study Arms (2)

OMT

EXPERIMENTAL

patients under standard medical care plus OMT.

Other: osteopathic manipulative treatment

Control

NO INTERVENTION

patients under standard medical care plus only osteopathic evaluation

Procedure: 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 PROCEDURE

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, \> 37 weeks;
• osteopathic treatment performed \> 14 days after birth;
• newborn transferred to/from other hospital;
• newborn from to HIV seropositive and/or drug addict mother;
• newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.

Sponsors & Collaborators

• European Institute for Evidence Based Osteopathic Medicine: lead

Study Sites (1)

Francesco Cerritelli

Pescara, 65124, Italy

Location

Related Publications (1)

• Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65.

  PMID: 23622070 DERIVED

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 Officials

• Francesco Cerritelli, DO, MS

  European Institute for Evidence Based Osteopathic Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: February 23, 2012
• First Posted: March 5, 2012
• Study Start: August 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 5, 2012

Record last verified: 2012-02

Locations

IT (1)