Condition category
Neonatal Diseases
Date applied
19/12/2017
Date assigned
15/01/2018
Last edited
13/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Enteral nutrition is a way to provide food through a tube placed in the nose, the stomach, or the small intestine. Gastric residual (GR) refers to the volume of fluid remaining in the stomach at a point in time during enteral nutrition feeding. It is routinely evaluated in preterm infants fed through a tube (routine GR aspiration). Not only there is no evidence to justify the use of the routine practice of GR aspiration, there is also no standard management of the GR. There are wide variations amongst neonatologists and between different neonatal intensive care units (NICUs) regarding the significance of the volume and color of the GR and the interval at which the GR should be checked. Nutrition in the NICU is considered one of the most challenging and important aspects of neonatal care to optimize the clinical outcomes of this fragile and at risk population. Routine GR aspiration can delay the achievement of full enteral feeding with its consequences of extra-uterine growth retardation, cholestasis and increased risk of sepsis. The aim of this study is to evaluate the effect of routine GR aspiration in preterm infants on reaching feed of 120cc/kg/day. It is thought that infants not receiving routine GR evaluation would reach a feed of 120cc/kg/day 3 days earlier than infants undergoing routine GR aspiration.

Who can participate?
Preterm infants at 32 weeks gestation or less

What does the study involve?
Participants are randomly allocated to one of two groups. Both groups strictly follow the feeding protocol as per the unit protocol. Infants in one group undergo routine gastric aspiration with pre-feeding aspiration every 6 hours. Infants in the other group proceed with feeding with no aspiration. Both groups strictly follow a scheme in case of having vomiting, abdominal distension or other GI symptoms. The number of days it takes to reach a feed of 120cc/kg/day is recorded. All infants are followed up until discharge.

What are the possible benefits and risks of participating?
Based on previous studies, patients not receiving routine GR aspiration may reach a full feed 6 days earlier and have fewer 6 days on central line. Possible risks include regurgitation and vomiting in the no aspiration group.

Where is the study run from?
King Abdulaziz University Hospital (Saudi Arabia)

When is the study starting and how long is it expected to run for?
December 2015 to December 2018

Who is funding the study?
King Abdulaziz University (Saudi Arabia)

Who is the main contact?
Dr Hala Aljariry
Haljariry@kau.edu.sa

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hala Aljariry

ORCID ID

http://orcid.org/0000-0002-7604-585X

Contact details

Department of Pediatrics
King Abdulaziz University
Jeddah
PO Box 80215 Jeddah 21589
Saudi Arabia
+966 (0)26401000 ext 20208
Haljariry@kau.edu.sa

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HA-02-J-008

Study information

Scientific title

Routine gastric residual aspiration in preterm infants and the effect on reaching full feed: a randomized controlled trial

Acronym

Study hypothesis

It is hypothesized that infants not receiving routine gastric residual (GR) evaluation would reach feed of 120cc/kg/day 3 days earlier than infants undergoing routine GR aspiration.

Ethics approval

Research Ethics Committee at King Abdulaziz University, 20/12/2015, ref: 396-15

Study design

Single-center unblinded randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Reaching full feed

Intervention

Prior to the experiment, a pilot study of 40 subjects was ran to obtain the variance estimates needed in determining the sample size. With the existing feeding protocol in the unit, the average time for infants less than or equal to 32 weeks to reach 120 ml/kg/day of feeding was 12 days (SD 6 days). It is hypothesized that no routine gastric aspirate will decrease the number of days to reach 120 ml/kg/day by 3 days. One hundred and twenty six patients were required to have an 80% chance of detecting, as significant at the 5% level, a three day decrease in the number of days to reach 120 ml/kg/day of feeding in the no routine gastric aspirate group.

An independent researcher provided sequentially numbered, opaque and sealed allocation envelops using computer generated random numbers. The envelopes are kept in the NICU in a locked cabinet and it is the responsibility of the in-charge nurse in NICU to open the cabinet when a patients is identified to be included in the study and after obtaining an informed written consent from one of the parents.

Both groups will strictly follow the feeding protocol as per the unit protocol. Infants undergoing routine gastric aspiration will have pre-feeding aspiration every 6 hours. Infants in the no routine aspiration group will proceed with feeding with no aspiration and both groups will strictly follow a scheme in case of having vomiting, abdominal distension or other GI symptoms. The number of days till reaching feed of 120cc/kg/day will be documented. All infants will be followed up until discharge.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

The number of days until reaching feed of 120cc/kg/day

Secondary outcome measures

1. The number of days until reaching feed of 150 cc/kg/day
2. The number of days on parenteral nutrition (from admission until the time of reaching full feed)
3. The number of days until the removal of central lines (from the day of insertion upon admission or afterward before reaching full feed until removal)
4. The incidence of sepsis, defined as positive blood culture, throughout the hospital stay until discharge
5. The incidence of necrotizing enterocolitis, based on Bell staging stage 2 or more, throughout the hospital stay until discharge
6. Growth parameters: weight measured at 7, 14 and 21 days to get the average of weight gain gm/kg/day

Overall trial start date

20/12/2015

Overall trial end date

15/03/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Preterm infants equal or less than 32 weeks gestation

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

126

Participant exclusion criteria

1. Any proved or suspected chromosomal abnormalities
2. Any gastrointestinal tract abnormalities
3. Patients with hypoxic ischemic insult

Recruitment start date

11/04/2016

Recruitment end date

15/01/2019

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

King Abdulaziz University Hospital
Jeddah
21589
Saudi Arabia

Sponsor information

Organisation

King Abdulaziz University

Sponsor details

PO Box 80215
Jeddah
21589
Saudi Arabia
+966 (0)26401000 ext 20208
Haljariry@kau.edu.sa

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

King Abdulaziz University

Alternative name(s)

King Abdulaziz University of Saudi Arabia, KAU

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Saudi Arabia

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Hala Aljariry (haljariry@kau.edu.sa). The data will be available once the recruitment is completed. SPSS for Windows, version 21.0 (SPSS, Chicago, IL, USA) is used. A written consent was taken from the parents and a copy was kept with them, an additional copy in the patients file and a copy with the investigator. No ethical or legal restrictions.

Intention to publish date

15/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/11/2018: The following changes were made: 1. The recruitment end date was changed from 11/10/2018 to 15/01/2019. 2. The overall trial end date changed from 15/12/2018 to 15/03/2019.