Rapid versus slow rate advancement of feeds for enterally fed extremely low birth weight infants ≤1000g
| ISRCTN | ISRCTN96923718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96923718 |
| Secondary identifying numbers | HREC REF 283/2011 |
- Submission date
- 28/09/2011
- Registration date
- 07/12/2011
- Last edited
- 21/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
30 Chukker Rd
Kenwyn
Cape Town
7780
South Africa
| Phone | +27 82 312 4819 |
|---|---|
| shukriraban@yahoo.co.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request patient info sheet |
| Scientific title | Rapid versus slow rate advancement of feeds for enterally fed extremely low birth weight infants ≤1000g: a randomised controlled trial |
| Study objectives | 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(s) | University of Cape Town, Faculty of Health Sciences- Human Research Ethics Committee approved on 26/07/2011, ref: HREC 283/2011 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 08/09/2011 |
| Completion date | 08/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | All inborn infants less than or equal to 1000g |
| Key exclusion criteria | 1. All outborn infants 2. Congenital abnormalities which would preclude feeds or immediately life threatening |
| Date of first enrolment | 08/09/2011 |
| Date of final enrolment | 08/09/2013 |
Locations
Countries of recruitment
- South Africa
Study participating centre
7780
South Africa
Sponsor information
University/education
School of Child and Adolescent Health
Division: Neonatal Medicine
H46 OMB
Groote Schuur Hospital
Observatory
Cape Town
7925
South Africa
| Website | http://www.scah.uct.ac.za/Neonatology.html |
|---|---|
"ROR" |
https://ror.org/03p74gp79 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | 21/01/2019 | Yes | No |
Editorial Notes
21/01/2019: Publication reference added
