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

NCT ID: NCT01407991

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-11-30

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.

Conditions

Enteral Tube Placement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

enteral tube placement accuracy

Intervention Type: OTHER

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

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).

Group Type: ACTIVE_COMPARATOR

NEM method for NG/OG tube placement

Intervention Type: OTHER

measure distance from the mouth to the ear and then the ear to mid abdomen and mark the tube to insert to that length

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Ely, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 11867979 (View on PubMed)

Other Identifiers

10-007863

Identifier Type: -

Identifier Source: org_study_id