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

Placement of NG or OG Tube in Infants by Length Versus Traditional Measuring Methods

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.

Study Overview

• Status: Terminated
• Conditions: Enteral Tube Placement
• Intervention / Treatment: Other: enteral tube placement accuracy; Other: NEM method for NG/OG tube placement

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate safety and efficacy of Nasogastric/Orogastric tube placement using the length method	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare depth ( too high, center, or too low) of NG/OG tube between the length method and the NEM method	Radiologist blinded to the randomized method of insertion will determine location of placement.	X-ray outcome of NG/OG placement will be measured after every 10 subjects complete the study, on average 4 weeks.

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Elizabeth Ely, PhD, RN, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• Klasner AE, Luke DA, Scalzo AJ. Pediatric orogastric and nasogastric tubes: a new formula evaluated. Ann Emerg Med. 2002 Mar;39(3):268-72. doi: 10.1067/mem.2002.120124.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: August 1, 2011
• First Posted (Estimate): August 2, 2011

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Enteral tube placement
• Other Study ID Numbers: 10-007863

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No