Condition category
Pregnancy and Childbirth
Date applied
28/09/2011
Date assigned
07/12/2011
Last edited
18/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims?
The best way of feeding by injection has not been established in preterm infants especially those weighing less than 1000g.This is because uncertainty exists regarding when to initiate feeds and how fast feeds should be advanced. The uncertainty is based on studies which raised concerns that early and rapid feeding strategies may be cause an infection of the gut called Necrotising Enterocolitis (NEC).

The aim of the study is to establish how well commencing milk feeds at 24ml/kg on the day of birth and advancing feeds at 36ml/kg/d, in babies with a birth weight at or below 1000g will work.

Who can participate?
Infants weighing ≤1000g at birth can participate.
Infants cannot participate if any of the following is present:
1. Any congenital abnormalities which makes enteral feeding (via stomach or intestine) impossible and is life threatening
2. Any infants delivered outside of the centre where the study takes place

What does the study involve?
Infants will be randomly allocated to one of four groups:
1. Low volume initiation + slow advancement
2. Low volume initiation + rapid advancement
3. High volume initiation + slow advancement
4. High volume initiation + rapid advancement
Allocation to one the groups will also depend on weight (<700g and 701-999g) and gender.

What are the possible benefits and risks of participating?
Rapid advancement feeding strategies would improve growth and nutrition and potentially reduce infection rates. Fewer intravenous lines would be inserted. Hospital stays would become shorter.

As both feeding regimens are in routine use it is not expected that an unexpected adverse reaction suspected to be caused by one of the feeding regimens is likely to occur

Where is the study run from?
The study will be conducted in the neonatal unit at Groote Schuur Hospital in Cape Town, South Africa.

When is the study starting and how long is it expected to run?
The study started recruiting on the 8 August 2011. We hope to recruit 200 patients over a period of 2 years.

Who is funding the study?
Incidental costs will be funded by the principal investigator

Who is the main contact?
Dr M Shukri Raban (principal investigator)
shukriraban@yahoo.co.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Shukri Raban

ORCID ID

Contact details

30 Chukker Rd
Kenwyn
Cape Town
7780
South Africa
+27 82 312 4819
shukriraban@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HREC REF 283/2011

Study information

Scientific title

Rapid versus slow rate advancement of feeds for enterally fed extremely low birth weight infants ≤1000g: a randomised controlled trial

Acronym

Study hypothesis

Infants ≤1000g at the study site currently have their feeds initiated on day 1 at 4ml/kg/day and are advanced to 24ml/kg/day until they reach full enteral feeds at a volume of 150ml/kg, thereafter the feeds will be increased till a volume of 200ml/kg is reached. This usually takes +/- 10 days. Additionally these infants will also receive FM85, multivitamins, 5% sodium chloride, phosphate sandoz and iron supplementation. The study aims to show that the intervention of initiating feeds at a high or low volume then advancing the feeds at 36ml/kg/d, results in better growth patterns as demonstrated in the time to attain a weight of 1500g but also in serial length and head circumference measurements, take fewer days to full enteral feeds, require fewer or no days of total parenteral nutrition and a potentially shorter hospital stay. The study also tests the hypothesis that fast feeding strategies will not increase the background incidence of necrotising enterocolitis (NEC) or mortality.

Ethics approval

University of Cape Town, Faculty of Health Sciences- Human Research Ethics Committee approved on 26/07/2011, ref: HREC 283/2011

Study design

Randomised controlled 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 contact details below to request patient info sheet

Condition

Low birth weight

Intervention

Randomised into four groups

1. Low volume initiation + slow advancement
2. Low volume initiation + rapid advancement
3. High volume initiation + slow advancement
4. High volume initiation + rapid advancement

Low volume initiation: Feeding will be initiated on the first day with 4ml/kg of expressed human breast milk (EBM) or donor human breast milk (DEBM)

High volume initiation: Feeding will be initiated on the first day with 24ml/kg of EBM/DEBM

Slow advancement: On day 2 the infant will receive 12ml/kg/day of EBM/DEBM. Thereafter the feeds will be increased in increments of 24ml/kg/day until enteral feeds of 200ml/kg/day are attained. If the infant is randomised to the high initiation + slow advancement arm; Feeding will be initiated on the first day with 24ml/kg/d of EBM/DEBM, on day 2 the infant will receive 24ml/kg/d .Thereafter the feeds will be increased in increments of 24ml/kg/day until enteral feeds of 200ml/kg/day are attained.

Rapid advancement: After day 1, the feeds will be increased in increments of 36ml/kg/day until enteral feeds of 200ml/kg/day are attained.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Multivitamins, 5% sodium chloride, phosphate , iron supplementation

Primary outcome measures

Time to attain 1500g weight

Secondary outcome measures

1. Clinical
1.1. Time to regain birth weight
1.2. Ttime to discharge
1.3. Mortality
1.4. Days nil by mouth
1.5. Necrotising enterocolitis (NEC)
1.6. Death before discharge
1.7. Growth in head circumference to discharge
1.8. Growth in length to discharge
1.9. The need for total parenteral nutrition (TPN)
2. Health services resource utilisation
2.1. Days of parenteral nutrition
2.2. Time to death or discharge

Overall trial start date

08/09/2011

Overall trial end date

08/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All inborn infants less than or equal to 1000g

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. All outborn infants
2. Congenital abnormalities which would preclude feeds or immediately life threatening

Recruitment start date

08/09/2011

Recruitment end date

08/09/2013

Locations

Countries of recruitment

South Africa

Trial participating centre

30 Chukker Rd
Cape Town
7780
South Africa

Sponsor information

Organisation

University of Cape Town (South Africa)

Sponsor details

School of Child and Adolescent Health
Division: Neonatal Medicine
H46 – OMB
Groote Schuur Hospital
Observatory
Cape Town
7925
South Africa

Sponsor type

University/education

Website

http://www.scah.uct.ac.za/Neonatology.html

Funders

Funder type

Other

Funder name

Investigator initiated and funded (South Africa)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes