Nasogastric Versus Orogastric Route of Feeding in Preterm (<32 Weeks) Neonates

NCT03073993 | Completed DMC

• 1 other identifier: NGOG
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Enteral feeding tubes in newborns are used for feeding preterm and low birth weight babies in neonatal intensive care units as they often do not suck effectively owing to lack of coordination between sucking, swallowing and breathing due to neurological immaturity and delayed gastric emptying. The feeding tubes could be inserted by the nasogastric (NG) route or by the orogastric (OG) route. Both routes are used in different Neonatal Intensive Care Units (NICUs). Both methods are associated with different adverse events. Since newborn infants are obligate nose breathers, nasogastric tube (NGT) can lead to partial nasal obstruction which might increase airway resistance and work of breathing although they are easy to secure to the face than orally placed tubes. Orogastric tubes (OGT), on the other hand, may not lead to the potential risk of increased work of breathing associated with NGT but are more frequently malpositioned and can loop inside the mouth. Also there is increased possibility of apnea and bradycardia due to vagal stimulation. Despite so many years of continuing debate, the evidence of superiority of one method over another is not proven. Very few studies have tried to look into this matter and there are no consensus guidelines. This study is being conducted to compare the rate and type of adverse events in OG versus NG feeds in preterm neonates ≤ 32 weeks and postmenstrual age (PMA) ≤ 36 weeks. Preterm neonates born at ≤ 32 weeks with PMA≤ 36 weeks who require feeding tube as a route for enteral feeding once they are out of respiratory support ( i.e ventilation or CPAP) are eligible candidates. Feeding tube insertion episode (FTIE) is defined as episode of insertion of OG or NG tube. FTIE will be randomized into NG or OG routes. Primary outcome is frequency of desaturation and bradycardia in each group.

Conditions

Apnea Prematurity

Keywords

nasogastric; orogastric; nutrition; preterm; feeding tube; insertion; episodes; bradycardia; desaturation

Outcome Measures

Primary Outcomes (1)

• Heart rate and saturation

  frequency of episodes of heart rate \<100 and sauration \< 85%

  48 hours

Secondary Outcomes (1)

• infant feeding tube

  48 hours

Study Arms (2)

Nasogastric

ACTIVE COMPARATOR

Feeding tube insertion in nasogastric group

Procedure: feeding tube insertion

Orogastric

ACTIVE COMPARATOR

Feeding tube insertion in orogastric group

Procedure: feeding tube insertion

Interventions

feeding tube insertion PROCEDURE

Feeding tube was inserted in hemodynamically stable babies for purpose of feeding

Nasogastric; Orogastric

Eligibility Criteria

• Age: 25 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Hemodynamically stable preterm neonates (≤32 weeks gestational age and PMA ≤ 36weeks) not requiring respiratory support (CPAP/Heated humidified high flow oxygen/ Ventilation).

You may not qualify if:

• Babies (\> 32 weeks and PMA\>36 weeks)
• Severe congenital malformations, chromosomal abnormalities
• Baby requiring any respiratory support
• Sepsis, IVH, NEC or any illness explaining apneas

Sponsors & Collaborators

• Max Super Speciality Hospital: lead

Related Publications (1)

• Bohnhorst B, Cech K, Peter C, Doerdelmann M. Oral versus nasal route for placing feeding tubes: no effect on hypoxemia and bradycardia in infants with apnea of prematurity. Neonatology. 2010;98(2):143-9. doi: 10.1159/000279617. Epub 2010 Mar 16.

  PMID: 20234138 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Bradycardia

Interventions

Intubation, Gastrointestinal

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intubation; Therapeutics; Investigative Techniques

Study Officials

• Naveen P Gupta, MD, DNB

  Consultant Neonatologist

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DNB Resident in Pediatrics

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: March 8, 2017
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share