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Nasogastric/Oral Gastric Tube Placement in Infants: Comparing 2 Measurement Methods

This study has suspended participant recruitment.
(Study terminated due to change in clinical practice affecting recruitment. For majority of patients, NJ tubes are now used instead of NG tubes.)
Sponsor:
Information provided by (Responsible Party):
Elizabeth Ely, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01407991
First received: July 25, 2011
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to compare two methods of nasogastric/oral gastric (NG/OG) tube placement for efficacy and safety in the placement of NG/OG tube in infants less than 6 months of age. One method is based on the infant's length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method) and the other method is based on current standard of care, measuring from the nose to the ear and then the ear to mid abdomen (NEM) and mark the tube to know how far to insert the tube. Outcome comparison will be xray verification of placement.


Condition Intervention Phase
Enteral Tube Placement
Other: enteral tube placement accuracy
Other: NEM method for NG/OG tube placement
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Placement of NG or OG Tube in Infants by Length Versus Traditional Measuring Methods

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Evaluate safety and efficacy of Nasogastric/Orogastric tube placement using the length method [ Time Frame: Participants will be followed for the duration of hospitalization, an average expected time of 4 weeks. Once an OG/NG tube change is completed per study protocol the participant will have completed the study. ] [ Designated as safety issue: Yes ]
    During the same day of NG/OG tube placement, verification of placement will be performed by bedside nurse as per institutional standards. X-ray verification will be done in batches (not same day) and read by radiologist blind to insertion method.


Secondary Outcome Measures:
  • compare depth ( too high, center, or too low) of NG/OG tube between the length method and the NEM method [ Time Frame: X-ray outcome of NG/OG placement will be measured after every 10 subjects complete the study, on average 4 weeks. ] [ Designated as safety issue: Yes ]
    Radiologist blinded to the randomized method of insertion will determine location of placement.


Estimated Enrollment: 72
Study Start Date: July 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Length or graph method
The graph method is based on the infants' length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method). The graph method has been tested in the pediatric population but not in infants under six months of age (Klazner, Luke and Scalso, 2002). Using a graph method might reduce some of the variability in placement. We propose to extend the Klazner, Luke and Scalso (2002) study in the infant population.
Other: enteral tube placement accuracy
The graph method is based on the infants' length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method). The graph method has been tested in the pediatric population but not in infants under six months of age (Klazner, Luke and Scalso, 2002). Using a graph method might reduce some of the variability in placement. We propose to extend the Klazner, Luke and Scalso (2002) study in the infant population.
Active Comparator: NEM method for NG/OG tube placement
Standard method- measure distance from the mouth to the ear and then the ear to mid abdomen and mark the tube to insert to that length. Nose to ear to mid-xiphoid-umbilicus (NEM).
Other: NEM method for NG/OG tube placement
measure distance from the mouth to the ear and then the ear to mid abdomen and mark the tube to insert to that length

Detailed Description:

Preterm infants often require nutritional intake through a nasogastric or oral gastric tube to meet their high energy requirement and avoid aspiration of nutrition due to their immature suck/swallow reflex. When providing nutrition via an NG or OG tube, there are two basic safety issues; accurate placement, determined by the end of the tube reaching the mid abdominal area, and verification methods to assure placement is optimal. Based on a review of relevant literature, a potentially more accurate method of tube placement is available than the method used in current practice. We hypothesize the graph method will result in a more accurate and less variable placement of the NG tube into the mid-stomach of preterm infants than the current standard using the NEM method.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants less than 6 months of age in the neonatal intensive care unit (NICU) regardless of gestational age
  2. Infants requiring an NG or OG tube for enteral feeds
  3. Infants whose NG tube is placed by the bedside Registered Nurse (RN)
  4. Parents need to speak and read English
  5. Infant scheduled for X-Ray for standard of care (SOC) within 24hrs of scheduled NG/OG tube change or placement.

Exclusion Criteria:

  1. Infants with congenital or structural anomalies of the GI tract
  2. Infants with significant scoliosis
  3. Infants with salem sump or repogle tube
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407991

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Elizabeth Ely, PhD, RN Children's Hospital of Philadelphia
  More Information

Publications:
Responsible Party: Elizabeth Ely, Nurse Researcher, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01407991     History of Changes
Other Study ID Numbers: 10-007863
Study First Received: July 25, 2011
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Enteral tube placement

ClinicalTrials.gov processed this record on November 23, 2014