Very Low Birth Weight InfantNCT07229885
Comparison of Early Versus Late Trophic Feeding
A study testing Early trophic feeding and Late trophic feeding in people with Very Low Birth Weight Infant, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
Local data on the neonatal outcomes in early versus late trophic feeding in preterm very low birth weight neonates in terms of mean hospital stay is scarce. Therefore, the current study was planned with the objective of comparing the neonatal outcomes in early versus late trophic feeding in preterm very low birth… Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- Early trophic feeding and Late trophic feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2025to 1 Oct 2025
- 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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any gender
- Neonates aged 1-30 days
- Preterm very low birth weight neonates
Who cannot join
- Neonates transferred from other hospital and already started on antibiotics.
- Neonates with congenital anomalies, hypoxic ischemic encephalopathy, central nervous system (CNS) impairment, neonatal sepsis, urinary tract infection, or one of twins or higher order multiples (on history and medical record).
- Non-consenting parents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Early Versus Late Trophic Feeding in Preterm Very Low Birth Weight Neonates at a Tertiary Care Hospital
Local data on the neonatal outcomes in early versus late trophic feeding in preterm very low birth weight neonates in terms of mean hospital stay is scarce. Therefore, the current study was planned with the objective of comparing the neonatal outcomes in early versus late trophic feeding in preterm very low birth weight neonates in terms of mean hospital stay.
Read the detailed description
Since preterm, very low birth weight births are common in society, an effective treatment modality is needed at the moment. Evaluating the length of hospital stay and occurrence of necrotizing enterocolitis in preterm very low birth weight neonates with respect to two approaches of trophic feeding in local settings will provide an insight into a better implementation of preventive strategies, resulting in reducing the hospital stays and the incidence of necrotizing enterocolitis, and hence reducing the burden on the already meager resources.
- Conditions
- Very Low Birth Weight Infant
- Being tested
- Early trophic feeding, Late trophic feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early trophic feedingDietary supplement
Infants will receive trophic (enteral) feeding within the first 48 hours after birth.
Late trophic feedingDietary supplement
Infants will receive trophic (enteral) feeding within the first 72 hours after birth.
| Study group | Role | What they receive |
|---|---|---|
| Early trophic feeding group | Experimental | Infants will receive trophic (enteral) feeding within the first 48 hours after birth. Receives: Dietary Supplement: Early trophic feeding |
| Late trophic feeding group | Experimental | Infants will receive trophic (enteral) feeding after 72 hours after birth. Receives: Dietary Supplement: Late trophic feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of necrotizing enterocolitis
Confirmation of the occurrence of necrotizing enterocolitis based on modified Bell's diagnostic criteria
Measured: Up to 30 days
Secondary outcomes (1)
Hospital stay
Total days from admission till final outcome (discharge/death due to any case).
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start15 May 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Nadeem Akram, Principal investigator, Nishter Hospital Multan, PakistanSulaiman Ali, FCPS, Study director, Nishter Hospital Multan, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229885
- Sponsor's protocol ID
- Dr-Nadeem-Nishter
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Versus Late Trophic Feeding in Preterm Very Low Birth Weight Neonates at a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT07229885
- Acronym / sponsor ID
- Dr-Nadeem-Nishter
- Conditions
- Very Low Birth Weight Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 17 Nov 2025 (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.
Local data on the neonatal outcomes in early versus late trophic feeding in preterm very low birth weight neonates in terms of mean hospital stay is scarce. Therefore, the current study was planned with the objective of comparing the neonatal outcomes in early versus late trophic feeding in preterm very low birth weight neonates in terms of mean hospital stay.
Detailed description
Since preterm, very low birth weight births are common in society, an effective treatment modality is needed at the moment. Evaluating the length of hospital stay and occurrence of necrotizing enterocolitis in preterm very low birth weight neonates with respect to two approaches of trophic feeding in local settings will provide an insight into a better implementation of preventive strategies, resulting in reducing the hospital stays and the incidence of necrotizing enterocolitis, and hence reducing the burden on the already meager resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early trophic feeding group | Experimental | Dietary Supplement: Early trophic feedingInfants will receive trophic (enteral) feeding within the first 48 hours after birth. |
| Late trophic feeding group | Experimental | Dietary Supplement: Late trophic feedingInfants will receive trophic (enteral) feeding after 72 hours after birth. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Any gender
- Neonates aged 1-30 days
- Preterm very low birth weight neonates
Key exclusion criteria (3 listed)
- Neonates transferred from other hospital and already started on antibiotics.
- Neonates with congenital anomalies, hypoxic ischemic encephalopathy, central nervous system (CNS) impairment, neonatal sepsis, urinary tract infection, or one of twins or higher order multiples (on history and medical record).
- Non-consenting parents.
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 |
|---|---|---|
| Early trophic feedingInfants will receive trophic (enteral) feeding within the first 48 hours after birth. | Dietary supplement | Early trophic feeding group |
| Late trophic feedingInfants will receive trophic (enteral) feeding within the first 72 hours after birth. | Dietary supplement | Late trophic feeding group |
Primary outcome
Incidence of necrotizing enterocolitis
Time frame: Up to 30 days
Confirmation of the occurrence of necrotizing enterocolitis based on modified Bell's diagnostic criteria
1 secondary outcome
Hospital stay
Time frame: through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided. Data can be shared on a reasonable request.
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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.
Nadeem Akram principal investigator
Nishter Hospital Multan, Pakistan
Sulaiman Ali, FCPS study director
Nishter Hospital Multan, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early trophic feeding and Late trophic feeding in people with Very Low Birth Weight Infant, run by RESnTEC, Institute of Research at 1 site in Pakistan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 17 Nov 2025. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of necrotizing enterocolitis (time frame: Up to 30 days). 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 17 Nov 2025.