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

Phase 2

Terminated

• Conditions: Enteral Tube Placement
• Interventions: Other: enteral tube placement accuracy; Other: NEM method for NG/OG tube placement

• Registration Number: NCT01407991
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

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.

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Length or graph method	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.
NEM method for NG/OG tube placement	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).

Primary Outcome Measures

Name	Time	Method
Evaluate safety and efficacy of Nasogastric/Orogastric tube placement using the length 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.	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

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

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States