ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000676910

Ethics application status

Approved

Date submitted

3/07/2011

Date registered

5/07/2011

Date last updated

11/07/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

2 hourly versus 3 hourly feeding in premature infants: A randomised control trial

Scientific title

The effect of 2 hourly versus 3 hourly feeding on duration to full feeding and body mass in premature infants

Secondary ID [1]

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Feeding premature infant

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Premature infants will be given 3 hourly feeding
1. All infants will be given IV dextrose 10% or TPN at 65 to 80mls per kg per day at the first hour of life
2. Enteral feeding will be started before 96 hours of life
3. All infants will be fed with expressed breast milk
4. If mother's breast milk is insufficient preterm formula is added
5. Feeding will be started at 10 to 20mls pe r kg per day
6. Advancement of the feeding at 10 to 20mls per kg per day 7. All the infants will be fed via oral gastric tube
8. Oral gastric tube placement by staff nurse using pre established technique
9. Feeding will be given over 15 to 30 minutes with gravity depending on the volume of the milk
10. Gastric residual will be checked immediately before feeding unless requested by the managing team of not doing so.
11. If any clinical signs of enteral intolerance and/or severe medical instability were noted, then the feeding volume will be reduced or the feedings will temporarily withheld according to clinical routines.
12. TPN will be started at least before 24 hours of life, the volume is increase 15mls/kg/day to a target volume of 140 to 160 ml/kg/day
13. When enteral feedings reached 100mls/kg of the total target volume, TPN will be discontinued.
14. Pre feeding dextrostic will be monitore d every shift (8 hourly) for 48hour to observe episode of hypoglycaemia in the infants
15. Urine ketone also will be monitored every day for 48 hour once the IVD is off.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Premature infants who are on 2 hourly feeding. The control group will go through the similar feeding protocol as the intervention group except that the feeding schedule where they will be given 2 hourly feeding while the intervention group will get 3 hourly feeding.
Feeding Protocol

1. All infants will be given IV dextrose 10% or TPN at 65 to 80mls per kg per day at the first hour of life
2. Enteral feeding will be started before 96 hours of life
3. All infants will be fed with expressed breast milk
4. If mother's breast milk is insufficient preterm formula is added
5. Feeding will be started at 10 to 20mls pe r kg per day
6. Advancement of the feeding at 10 to 20mls per kg per day
7. All the infants will be fed via oral gastric tube
8. Oral gastric tube placement by staff nurse using pre established technique
9. Feeding will be given over 15 to 30 minutes with gravity depending on the volume of the milk
10. Gastric residual will be checked immediately before feeding unless requested by the managing team of not doing so.
11. If any clinical signs of enteral intolerance and/or severe medical instability were noted, then the feeding volume will be reduced or the feedings will temporarily withheld according to clinical routines.
12. TPN will be started at least before 24 hours of life, the volume is increase 15mls/kg/day to a target volume of 140 to 160 ml/kg/day
13. When enteral feedings reached 100mls/kg of the total target volume, TPN will be discontinued.
14. Pre feeding dextrostic will be monitore d every shift (8 hourly) for 48hour to observe episode of hypoglycaemia in the infants
15. Urine ketone also will be monitored every day for 48 hour once the IVD is off.

Control group

Active

Outcomes

Primary outcome [1]

Day of achieving full feeding

Timepoint [1]

Day where the infants able to tolerate 100ml/kg/day of oral feeding

Primary outcome [2]

Day of regaining the birth weight

Timepoint [2]

Day where the infants get back their birth weight where the infant will be weight every other day until achieving the birth weight

Secondary outcome [1]

Secondary outcome 1: Episode of hypoglycaemia after achieving full feeding and TPN discontinued

Timepoint [1]

Timepoint: Dextrostix checked every 8 hourly for 48 hours after TPN discontinued

Eligibility

Key inclusion criteria

Premature infants of 34 weeks gestation and below
The birth weight of 1000gram to 1800gram

Minimum age

No limit

Maximum age

96 Hours

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Congenital Major Malformation include chromosomal abnormalities
2. Severe asphyxia
3. Congenital GIT abnormality such as esophageal atresia, TOF

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

1. All infants who fulfilled the inclusion criteria will be enrolled in this study.
2. Allocation sequence is generated independently by the person who has no role in the recruitment, treatment or assessment of the patient.
3.Concealment of allocation will be ensured using opaque sealed envelopes containing the choice of feeding schedule.
4. No blinding (impossible)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Block randomisation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/06/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Short Term Grant, School Of Medical Sciences, Universiti Sains Malaysia

Address [1]

School Of Medical Sciences, Universiti Sains Malaysia,
Kubang Kerian, 16150,
Kelantan

Country [1]

Malaysia

Primary sponsor type

University

Name

Short Term Grant, School Of Medical Sciences, Universiti Sains Malaysia

Address

School Of Medical Sciences, Universiti Sains Malaysia,
Kubang Kerian, 16150,
Kelantan

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics Committee (Human)

Ethics committee address [1]

Clinical Sciences Research Platform Office, Universiti Sains Malaysia, Kubang kerian,16150,
Kelantan

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

Approval date [1]

26/08/2010

Ethics approval number [1]

229.3.(01)

Ethics committee name [2]

National Medical Research Register,

Ethics committee address [2]

Ministry Of Health Research and Ethics Committee, 
National Institute of Health(NIH) Secretariat
Ministry of Health Malaysia,
c/o Institute for Health Management,
Jalan Rumah Sakit, Bangsar,
50900 Kuala Lumpur.

Ethics committee country [2]

Malaysia

Date submitted for ethics approval [2]

Approval date [2]

11/04/2011

Ethics approval number [2]

NMRR-10-56-5166

Summary

Brief summary

Preterm delivery rates vary from 6% to 15% of all deliveries, with the rate increasing in recent years (Slattery and Morrison, 2002). In Malaysia 2006, about 3,153 were preterm babies below 32 weeks gestational age (GA) and 3,586 babies had birth weights of below 1501 (Irene Cheah, 2008)
As more immature preterm infants survive, provision of enteral feedings has become a major focus of concern. Feeding problems in preterm infant are varies from very mild form such as feeding intolerance to the most fatal one such as NEC with perforated gut.
For the past, enteral fasting was once used in VLBW as fear of NEC. However, currently early initiation of trophic feedings is recommended. (Sarah Bombell, William McGuire, 2009).
Tube feeding is necessary for most premature infants less than 1500 grams because of their inability to coordinate sucking, swallowing, and breathing (Schanler 1999) and the danger of aspiration (Valman 1972). Many studies had done for continuous versus bolus feeding in premature infant in the past. However, a Cochrane review has shown that small babies less than 1500 grams, fed by intermittent bolus compared with continuous infusion, took a shorter time to reach full feeds with no difference in somatic growth, days to discharge, or the incidence of necrotizing enterocolitis (Premji 2002).
As per conversation survey in October 2009, most of the NICU in Malaysia practice 3 hourly feeding regimes for those more then 1.5kg and 2 hourly feeding regimes for babies less then 1.5kg. However there was no organized randomized control trial to support this. 
In this study, we would like to test the hypothesis that extreme low birth weight infants able to tolerate 3 hourly feeding safely. By knowing that, we could establish a better feeding protocol and without compromised the infant’s health. Hopefully,the infants will receive better care if 3 hourly feeding is safe for them as nurses will have more time on other important nursing care. The infants also will have less disturbance if 3 hourly feeding can be adopted. It may also reduce the errors in preparation (50% less workload for nurses with regards to feeds) and fewer chances for contamination. Larger amount of feeding may cause some abdominal distension or probably may increase possibility of reflux thus we would like to look at it as the outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Nor Rosidah Ibrahim

Address

Department of Paediatric, School of Medical Science, Universiti Sains Malaysia, Kubang Kerian, 16150, Kelantan, Malaysia.

Country

Malaysia

Phone

Tel: +6019 9176902

Fax

Fax:+609 7647642

nrosidah@kb.usm.my

Contact person for scientific queries

Name

Dr Nor Rosidah Ibrahim

Address

Department of Paediatric, School of Medical Science, Universiti Sains Malaysia, Kubang Kerian, 16150, Kelantan, Malaysia.

Country

Maldives

Phone

+6019 9176902

Fax

+609 7647642

nrosidah@kb.usm.my

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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