Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000752662
Ethics application status
Approved
Date submitted
30/03/2023
Date registered
11/07/2023
Date last updated
11/07/2023
Date data sharing statement initially provided
11/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of early versus late initiation of trophic feeding in preterm infants.
Scientific title
Comparison of early versus late initiation of trophic feeding in preterm infants on duration of stay in high dependency unit.
Secondary ID [1] 308774 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prematurity 328736 0
Condition category
Condition code
Oral and Gastrointestinal 325736 325736 0 0
Normal oral and gastrointestinal development and function
Reproductive Health and Childbirth 327407 327407 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early trophic feed initiation will be done according to birth date admitted on their 1st or 2nd day of life comprising of expressed breast milk given at <48 hours postntal age of preterm infant delivered by Nursing staff in neonatal unit through Nasogastric tube every 2 hourly 1 to 2 ml in amount with a total of 12 feeds in 24 hours. Increasing the Nasogastric feeding daily by 2 ml till the end of stay or when neonate is able to tolerate oral feed.
Intervention code [1] 325237 0
Prevention
Comparator / control treatment
Late trophic feed initiation will be done according to birth date admitted on their 2nd or 3rd day of life comprising of expressed breast milk given at > 72 hours postnatal age of preterm infant by Nursing staff in neonatal unit through Nasogastric tube every 2 hourly. Each feed is 1 to 2 ml in amount administered 2 hourly with a total of 12 feeds in 24 hours.
Increasing the Nasogastric feeding daily by 2ml till the end of stay or till the preterm infant is able to tolerate oral feed.
Control group
Active

Outcomes
Primary outcome [1] 333586 0
Duration of stay of preterm infant in neonatal high dependency unit determined from hospital records.
Timepoint [1] 333586 0
Duration of stay of preterm infant in neonatal high dependency unit assessed in days at the time of hospital discharge.
Secondary outcome [1] 417647 0
Improved preterm survival in neonatal high dependency unit determined from hospital records.
Timepoint [1] 417647 0
At the time of discharge from neonatal high dependency unit of hospital.

Eligibility
Key inclusion criteria
Preterm 28 weeks to 36 weeks gestation.
Birth weight 1000 to 2500 g
Age<3 days postnatal age at time of admission
Minimum age
1 Days
Maximum age
2 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Preterm infants with major congenital anomaly.
Preterm infant on inotropic drug support.
Preterm infants with severe respiratory distress.
Preterm infants who developed any complications.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation by birth date
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
t test is used to compare the duration of stay in high dependency unit of both groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2023
Actual
Date of last participant enrolment
Anticipated
30/10/2023
Actual
Date of last data collection
Anticipated
20/11/2023
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 25217 0
Pakistan
State/province [1] 25217 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 312995 0
Hospital
Name [1] 312995 0
Lady reading hospital
Country [1] 312995 0
Pakistan
Primary sponsor type
Hospital
Name
Lady Reading Hospital
Address
Paediatric ward MTI LRH Peshawar, Soekarno Rd, PTCL Colony Peshawar, Khyber Pakhtunkhwa 25000, Pakistan.
Country
Pakistan
Secondary sponsor category [1] 314677 0
None
Name [1] 314677 0
Address [1] 314677 0
Country [1] 314677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312259 0
Institutional Review Board,MTI LRH Peshawar
Ethics committee address [1] 312259 0
Ethics committee country [1] 312259 0
Pakistan
Date submitted for ethics approval [1] 312259 0
22/02/2023
Approval date [1] 312259 0
08/03/2023
Ethics approval number [1] 312259 0
678/LRH/MTI

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124018 0
A/Prof Rabiya Munir
Address 124018 0
Paediatric ward LRH, Paediatric ward MTI LRH Peshawar, Soekarno Rd, PTCL Colony Peshawar, Khyber Pakhtunkhwa 25000, Pakistan.
Country 124018 0
Pakistan
Phone 124018 0
+923465324232
Fax 124018 0
Email 124018 0
[email protected]
Contact person for public queries
Name 124019 0
Rabiya Munir
Address 124019 0
Paediatric ward LRH, Paediatric ward MTI LRH Peshawar, Soekarno Rd, PTCL Colony Peshawar, Khyber Pakhtunkhwa 25000, Pakistan.
Country 124019 0
Pakistan
Phone 124019 0
+923465324232
Fax 124019 0
Email 124019 0
[email protected]
Contact person for scientific queries
Name 124020 0
Rabiya Munir
Address 124020 0
Paediatric ward LRH, Paediatric ward MTI LRH Peshawar, Soekarno Rd, PTCL Colony Peshawar, Khyber Pakhtunkhwa 25000, Pakistan.
Country 124020 0
Pakistan
Phone 124020 0
+923465324232
Fax 124020 0
Email 124020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18663Ethical approval  [email protected]
18664Statistical analysis plan  [email protected]
18665Study protocol  [email protected]
18666Informed consent form  [email protected]
18765Other  [email protected] Data collection proforma


Updated to:
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.