PretermNCT06246032
Impact of Modified Feeding Protocol on Neonatal Outcomes
A study testing Modified feeding Protocol in people with Preterm and Birth Weight, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg. The main questions it aims to answer are: Is Modified feeding protocol will decrease the duration of parenteral nutrition and length of… Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Preterm, Birth Weight, Feeding Disorder Neonatal
- What is being tested?
- Modified feeding Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight (<2000g)
- Gestational Age (<37 week)
Who cannot join
- Metabolic Disorders
- Congenital Heart Diseases
- Chronic Lung Disease
- Congenital Anomalies (can related to feeding)
- Moderate to severe GERD
- Necrotizing enterocolitis stage 3 (surgical)
- Gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Maternity and Children Hospital
Dammam, Eastern Province
About this study
The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg.
The main questions it aims to answer are:
- Is Modified feeding protocol will decrease the duration of parenteral nutrition and length of hospital stay?
- Is Modified feeding protocol feasible, efficient, and safe in preterm infants?
Participants will undergo the modified feeding protocol since birth until discharge.
Read the detailed description
two group in this study Prospective group: intervention group will undergo the modified feeding protocol Retrospective group: intervention group will undergo the current feeding protocol
Both group will have care as routine care to this kind of patients But the differ will be in feeding protocol as initiation rate, advancement rate, human milk fortification rate
The outcomes of both group will be compeered to meet the study objectives
- Conditions
- Preterm, Birth Weight, Feeding Disorder Neonatal
- Being tested
- Modified feeding Protocol
- Keywords
- Feeding protocol, Neonates, Preterm, Very low birthweight, NICU
- Medical subject headings
- Premature Birth, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified feeding ProtocolOther
Initiation of feeding (fixed): 10cc/kg
Advancement based on birthweight (fixed):
<750g: 15cc/kg/d 750-999g: 20cc/kg/d 1000-1249g: 25cc/kg/d 1250-1499g: 25cc/kg/d 1500-1749g: 35cc/kg/d 1750-2000g: 35cc/kg/d
Starting Human milk fortification when feed reach at 70cc/kg/d
| Study group | Role | What they receive |
|---|---|---|
| Modified feeding Protocol | Experimental | Prospective Receives: Other: Modified feeding Protocol |
| Current feeding Protocol | No intervention | Retrospective data will be collected from medical record of patients undergo the current feeding protocol as follow Initiation of feeding (average): 8.7cc/kg (6-12cc/kg) Advancement based on birthweight (average): <750g: 20cc/kg/d (17-24cc/kg/d) 750-999g: 29cc/kg/d (25-34cc/kg/d) 1000-1249g: 22cc/kg/d (20-24cc/kg/d) 1250-1499g: 24cc/kg/d (21-25cc/kg/d) 1500-1749g: 20cc/kg/d (18-21cc/kg/d) 1750-2000g: 34cc/kg/d (32-36cc/kg/d) Starting Human milk fortification when feed reach at 120cc/kg/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay (LOS)
Number of days that participant stayed at hospital
Measured: Up to 8 weeks
Duration of Total Parenteral Nutrition (TPN)
Number of days that participant received Total Parenteral Nutrition (TPN)
Measured: up to 2 weeks
Secondary outcomes (2)
Incidence of Necrotizing Enterocolitis
Stage 2, Stage 3
Measured: Up to 8 weeks
Incidence of Feeding intolerance
abdominal grith more than 2 cm, gastric residual 50% of the last feed.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 May 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan AlQahtani, Imam Abdulrahman Bin Faisal University
- Investigators
- Hanan AlQahtani, Master, Principal investigator, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246032
- Sponsor's protocol ID
- IRB-PGS-2023-03-443
- Status last verified
- Feb 2024
- First submitted
- 5 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Modified Feeding Protocol on Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT06246032
- Acronym / sponsor ID
- IRB-PGS-2023-03-443
- Conditions
- Preterm, Birth Weight, Feeding Disorder Neonatal
- Keywords
- Feeding protocol, Neonates, Preterm, Very low birthweight, NICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg.
The main questions it aims to answer are:
- Is Modified feeding protocol will decrease the duration of parenteral nutrition and length of hospital stay?
- Is Modified feeding protocol feasible, efficient, and safe in preterm infants?
Participants will undergo the modified feeding protocol since birth until discharge.
Detailed description
two group in this study Prospective group: intervention group will undergo the modified feeding protocol Retrospective group: intervention group will undergo the current feeding protocol
Both group will have care as routine care to this kind of patients But the differ will be in feeding protocol as initiation rate, advancement rate, human milk fortification rate
The outcomes of both group will be compeered to meet the study objectives
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified feeding Protocol | Experimental | Other: Modified feeding ProtocolProspective |
| Current feeding Protocol | No intervention | –Retrospective data will be collected from medical record of patients undergo the current feeding protocol as follow Initiation of feeding (average): 8.7cc/kg (6-12cc/kg) Advancement based on birthweight (average): <750g: 20cc/kg/d (17-24cc/kg/d) 750-999g: 29cc/kg/d (25-34cc/kg/d) 1000-1249g: 22cc/kg/d (20-24cc/kg/d) 1250-1499g: 24cc/kg/d (21-25cc/kg/d) 1500-1749g: 20cc/kg/d (18-21cc/kg/d) 1750-2000g: 34cc/kg/d (32-36cc/kg/d) Starting Human milk fortification when feed reach at 120cc/kg/d |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Birth weight (<2000g)
- Gestational Age (<37 week)
Key exclusion criteria (7 listed)
- Metabolic Disorders
- Congenital Heart Diseases
- Chronic Lung Disease
- Congenital Anomalies (can related to feeding)
- Moderate to severe GERD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified feeding ProtocolInitiation of feeding (fixed): 10cc/kg Advancement based on birthweight (fixed): <750g: 15cc/kg/d 750-999g: 20cc/kg/d 1000-1249g: 25cc/kg/d 1250-1499g: 25cc/kg/d 1500-1749g: 35cc/kg/d 1750-2000g: 35cc/kg/d Starting Human milk fortification when feed reach at 70cc/kg/d | Other | Modified feeding Protocol |
Primary outcome
Length of Stay (LOS)
Time frame: Up to 8 weeks
Number of days that participant stayed at hospital
Duration of Total Parenteral Nutrition (TPN)
Time frame: up to 2 weeks
Number of days that participant received Total Parenteral Nutrition (TPN)
2 secondary outcomes
Incidence of Necrotizing Enterocolitis
Time frame: Up to 8 weeks
Incidence of Feeding intolerance
Time frame: Up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanan AlQahtani, Master principal investigator
Imam Abdulrahman Bin Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified feeding Protocol in people with Preterm and Birth Weight, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (LOS) (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.