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Fixation of the Orogastric Tube: Which Method for the Newborn ? (BABAFIX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04233333
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Brief Summary:

It is recommended to respect the perioral zone by fixing the feeding tube only on the newborn's cheek, in order to promote oral acquisition and avoid repeated dislodgment of probes (HAS). This rule is easily applicable for nasogastric tubes. The difficulty is found for orogastric tubes. The "mustache" is usually used to fix it, but this interferes with the perioral zone and must be changed more often than necessary.

To achieve a more sustainable orogastric tube's fixation to the cheek, a German team directed by W. Krämer developed and tested an orogastric tube's fixing technique that was subsequently approved and used.

Using this German method, a randomized, monocentric superiority study, including 30 newborns and premature babies requiring an orogastric tube, will compared german probe's fixation method to the mustache.

The aim of the study is to ensure a more effective orogastric tube's fixation to reduce the number of fixation changes, probe placements and negative oral stimulations in newborns.


Condition or disease Intervention/treatment Phase
Enteral Feeding Gastric Emptying Device: method of fixation of the orogastric tube Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Fixation of the Orogastric Tube: Which Method for the Newborn ?
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : February 11, 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Active Comparator: mustache fixation Device: method of fixation of the orogastric tube
Methods of fixation of the orogastric tube will be randomized

Experimental: W.K fixation Device: method of fixation of the orogastric tube
Methods of fixation of the orogastric tube will be randomized




Primary Outcome Measures :
  1. Average duration of holding the fixation [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Number of tube's dislodgements [ Time Frame: 7 days ]


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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newborns admitted to neonatal intensive care unit
  • Express consent of the holders of parental authority
  • Orogastric tube indication (enteral feeding, digestive aspiration)

Exclusion Criteria:

  • Newborns over 2 months of age corrected
  • Indication of nasogastric tube
  • Port of gastrostomy
  • Pathology resulting in hypersalivation or hyper sweating
  • Swallowing disorder
  • Genetic disease
  • Severe neurological impairment
  • Cleft lip and / or palate
  • Other malformation in the oral sphere or perioral area
  • Sedation with morphine analgesics
  • Anticonvulsant treatment
  • Palliative care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233333


Contacts
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Contact: Lucie AUZANNEAU (0)262 35 99 49 ext +262 lucie.auzanneau@chu-reunion.fr

Locations
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France
Centre Hospitalier Universitaire de la Réunion Recruiting
Saint-Pierre, France, 97448
Contact: Lucie AUZANNEAU         
Principal Investigator: Sylvie PAYET         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion

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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT04233333    
Other Study ID Numbers: 2017/CHU/08
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No