Feeding ToleranceNCT07409038
Growth and Feeding Tolerance in Premature Infants
A study testing early initiation of human milk fortification on feeding tolerance in people with Feeding Tolerance and Growth, run by Children's Hospital and Institute of Child Health, Multan at 1 site in Pakistan.
Trial summary
The main purpose of the study is to evaluate the effect of early human milk fortification versus delayed fortification on growth and feeding tolerance in premature infants. Read more about this study
- Who is it for?
- Ages 28 to 31 weeks
- Conditions the study is for
- Feeding Tolerance, Growth
- What is being tested?
- early initiation of human milk fortification on feeding tolerance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 28 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born at 28-31+6 weeks' gestation and/or birth weight1000-1500g.
- Exclusively receiving mother's own milk or donor human milk.
- No major congenital anomalies, severe sepsis, or NEC at enrollment.
- Parental/guardian consent
Who cannot join
- Extremely pre-term infants
- Infants with congenital gastrointestinal malformations or metabolic disorders.
- Infants with confirmed necrotizing enterocolitis(NEC)Stage II/III or intestinal perforation before enrollment (as these cases indicate significant gastrointestinal morbidity that may interfere with feeding tolerance and growth assessment).
- Infants whose parents decline participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
The Children's Hospital and The Institute of Child Health, Multan
Multan Khurd, Punjab Province, 60000
The Children's Hospital and The Institute of Child Health, Mul Medical Superintendent, (061) 9201431, childrenhospitalmultan@gmail.com
About this study
Official title: Effect of Early Human Milk Fortification Versus Delayed Fortification on Growth and Feeding Tolerance in Premature Infants: a Randomized Controlled Trial.
The main purpose of the study is to evaluate the effect of early human milk fortification versus delayed fortification on growth and feeding tolerance in premature infants.
- Conditions
- Feeding Tolerance, Growth
- Being tested
- early initiation of human milk fortification on feeding tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early initiation of human milk fortification on feeding toleranceDietary supplement
early initiation of human milk fortification on feeding tolerance
| Study group | Role | What they receive |
|---|---|---|
| delayed initiation of human milk fortification on feeding tolerance | Other | delayed initiation of human milk fortification on feeding tolerance Receives: Dietary Supplement: early initiation of human milk fortification on feeding tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
● ≥15-20 g/kg/day (or as per predefined growth standards for preterm infants).
Measured: 2 to 3 months
● Linear growth & head circumference
- Increase in length ≥0.8-1.0 cm/week.
- Head circumference growth ≥0.5-0.8 cm/week
Measured: 2 to 3 months
Secondary outcomes (2)
● Successful enteral feeding advancement
- Achievement of full enteral feeds (≥150 mL/kg/day) without interruption.
- No need for feed withholding or reduction due to intolerance
Measured: 2 to 3 months
● Absence of intolerance signs
- Gastric residuals <2-3 mL/kg per feed (non-bilious, non-bloody).
- No emesis, abdominal distension, or NEC (Bell's stage ≥II).
Measured: 2 to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding ToleranceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital and Institute of Child Health, Multan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Muhammad Asif, Children's Hospital and Institute of Child Health, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409038
- Sponsor's protocol ID
- CHMultan
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AlizadehTaheri,P.,Sajjadian, N.,AsGharyanFarge,M.,&Shariat,M.(2017).Isearlybreast milk fortification more effective in preterm infants? A clinical trial: Early and late fortification. InJournal of PerinatalMedicine(Vol. 45, Issue8, pp.953-957). Walter de Gruyter GmbH.https://doi.org/10.1515/jpm-2015-0375
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Human Milk Fortification Versus Delayed Fortification on Growth and Feeding Tolerance in Premature Infants: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07409038
- Acronym / sponsor ID
- CHMultan
- Conditions
- Feeding Tolerance, Growth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Children's Hospital and Institute of Child Health, MultanOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 13 Feb 2026 (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 main purpose of the study is to evaluate the effect of early human milk fortification versus delayed fortification on growth and feeding tolerance in premature infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| delayed initiation of human milk fortification on feeding tolerance | Other | Dietary Supplement: early initiation of human milk fortification on feeding tolerancedelayed initiation of human milk fortification on feeding tolerance |
Who may qualify
- Ages
- 28 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants born at 28-31+6 weeks' gestation and/or birth weight1000-1500g.
- Exclusively receiving mother's own milk or donor human milk.
- No major congenital anomalies, severe sepsis, or NEC at enrollment.
- Parental/guardian consent
Key exclusion criteria (4 listed)
- Extremely pre-term infants
- Infants with congenital gastrointestinal malformations or metabolic disorders.
- Infants with confirmed necrotizing enterocolitis(NEC)Stage II/III or intestinal perforation before enrollment (as these cases indicate significant gastrointestinal morbidity that may interfere with feeding tolerance and growth assessment).
- Infants whose parents decline participation.
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 initiation of human milk fortification on feeding toleranceearly initiation of human milk fortification on feeding tolerance | Dietary supplement | delayed initiation of human milk fortification on feeding tolerance |
Primary outcome
weight gain
Time frame: 2 to 3 months
● ≥15-20 g/kg/day (or as per predefined growth standards for preterm infants).
● Linear growth & head circumference
Time frame: 2 to 3 months
* Increase in length ≥0.8-1.0 cm/week. * Head circumference growth ≥0.5-0.8 cm/week
2 secondary outcomes
● Successful enteral feeding advancement
Time frame: 2 to 3 months
● Absence of intolerance signs
Time frame: 2 to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- BackgroundAlizadehTaheri,P.,Sajjadian, N.,AsGharyanFarge,M.,&Shariat,M.(2017).Isearlybreast milk fortification more effective in preterm infants? A clinical trial: Early and late fortification. InJournal of PerinatalMedicine(Vol. 45, Issue8, pp.953-957). Walter de Gruyter GmbH.https://doi.org/10.1515/jpm-2015-0375
- 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.
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 initiation of human milk fortification on feeding tolerance in people with Feeding Tolerance and Growth, run by Children's Hospital and Institute of Child Health, Multan 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Muhammad Asif Doctor, MBBS (00923143329514, drasif18june@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain (time frame: 2 to 3 months). 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?
On the ClinicalTrials.gov record for NCT07409038, which also lists 1 linked publication.
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 13 Feb 2026.