Clinical trial NCT01407991: Nasogastric/Oral Gastric Tube Placement in Infants: Comparing 2 Measurement Methods
Official title: Placement of NG or OG Tube in Infants by Length Versus Traditional Measuring Methods
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Enteral Tube Placement
Keywords: Enteral tube placement
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 9
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Evaluate safety and efficacy of Nasogastric/Orogastric tube placement using the length method
timeFrame: 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 outcomes:
measure: compare depth ( too high, center, or too low) of NG/OG tube between the length method and the NEM method
timeFrame: X-ray outcome of NG/OG placement will be measured after every 10 subjects complete the study, on average 4 weeks.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Elizabeth Ely, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.