Gastric Lipase Enhanced Nasogastric Tube Study in Neonates

NCT04271995 | Completed

• 1 other identifier: 19QC5444
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

The newborn infants who are sick and those who are born prior to due date (preterm) are admitted to the neonatal unit. These babies are unable to feed through their mouth, so a special tube is passed through their nose to the stomach, nasogastric (NG) tube) to provide milk feeds. The bedside nurse inserts the tube and then aspirate some of the fluid from the stomach. As the stomach normally produce acid, these aspirate is then tested on a colour coded paper strip to check if the fluid is acidic. However, on many occasions this test is not very clear. This could be due to misplacement of the tube or the stomach in a newborn not being able to produce enough acid. This then leads to re-siting of another tube and following the same procedure. Sometimes the clinical team may like to do an X Ray to check the position of the tube resulting in unnecessary exposure to radiation. The study will use a special chemical added to the currently existing paper test strip which the investigators believe will enhance the capability of detecting the correct position of the NG tube. This idea has been tested in adults and found to have increased the sensitivity of the test strip significantly. Based on the adult study the study will require to test 233 babies to see if this increases the sensitivity of correct NG tube placement. Parents of all babies who requires an NG tube for milk feeds will be approached and after appropriate consent could be recruited to the study. Babies who are clinically very unstable, moribund and those with diagnosis of bowel obstruction will be excluded from the study.

Conditions

Neonatal Disorder

Keywords

nasogastric tube; gastric lipase

Outcome Measures

Primary Outcomes (1)

• Sensitivity of standard and ingenza pH strips

  Where test sensitivity is defined as the proportion of pH readings that are equal to or below (\<=) a certain cut-off when aspirates are obtained from tubes placed inside the stomach. Stomach placements are confirmed either by chest x-rays, or in its absence, by clinical observations).

  6 months

Secondary Outcomes (5)

• Number of chest x rays performed

  6 months

• Time to confirm tube placement

  6 months

• Number of nasogastric tube attempts to get the correct pH

  6 months

• Specificity of standard and ingenza pH strips

  6 months

• pH readings obtained by standard and ingenza strips under all cut-offs

  6 months

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All infants admitted to the neonatal unit requiring insertion of nasogastric tube

You may qualify if:

• All infants (preterm and term) who require the insertion of nasogastric tubes for supplementary enteral feeding as part of their routine clinical management

You may not qualify if:

• Clinically unstable, critically ill infants
• Infants undergoing palliative care
• Infants with bowel conditions such as necrotising enterocolitis, bowel obstruction

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: March 2, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

GB (1)