Growth FailureIOCOIOPGIPINCT07082881
Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants
A study testing Colostrum and Normal Saline in people with Growth Failure and Preterm Birth, run by Suqian First Hospital.
Trial summary
The goal of this clinical trial is to ascertain whether oropharyngeal administration of colostrum contributes to postnatal growth in very preterm infants (those born before 32 weeks of gestation). Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Growth Failure, Preterm Birth, Microbiota
- What is being tested?
- Colostrum and Normal Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Sep 2028
- 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 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age <32 weeks and birth weight <1500 g;
- admitted to the NICU of one of the five hospitals mentioned above within 24 h of birth; and
- able to initiate the protocol within 72 h of birth and continuously provide adequate colostrum until the end of the protocol.
Who cannot join
- Death within 48 h;
- severe birth asphyxia (defined as umbilical artery/first-hour arterial blood gas pH < 7.0);
- birth with severe gastrointestinal malformations (e.g., intestinal atresia, tracheoesophageal fistula, malrotation of the intestines, and Hirschsprung's disease);
- prenatal diagnosis of congenital chromosomal abnormalities or suspected congenital genetic metabolic diseases; and
- maternal substance abuse or contraindications to breastfeeding (e.g., HIV).
About this study
Official title: Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants Based on Early Gut Microbiota-Host Interaction Patterns: A Protocol for a Randomized Controlled Trial
The goal of this clinical trial is to ascertain whether oropharyngeal administration of colostrum contributes to postnatal growth in very preterm infants (those born before 32 weeks of gestation). The main questions it aims to answer are:
Can Oropharyngeal administration of colostrum effectively lower the incidence rate of extrauterine growth restriction (EUGR) in participants? Does oropharyngeal colostrum intervention bring about changes in the early gut microbiota of participants? Researchers will conduct a comparative analysis between colostrum and a placebo (normal saline) to investigate whether oropharyngeal administration of colostrum has a beneficial effect on the postnatal growth of participants.
Read more
Participants will:
Initiation of oropharyngeal colostrum administration will take place within 48 - 72 hours after birth, and the treatment will be administered continuously for a period of 5 days.
Stool samples will be collected from the participants both before and after the intervention.
Participants will be required to maintain a diary to document their basic characteristics and clinical outcomes.
- Conditions
- Growth Failure, Preterm Birth, Microbiota
- Being tested
- Colostrum, Normal Saline
- Medical subject headings
- Failure to Thrive, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColostrumOther
The treatment group will undergo the following treatment protocol within the initial 48-72 h: Investigators will select storage bags with the closest lactation time to the current time while wearing sterile gloves for the entire procedure. Next, using two 1-mL sterile syringes, investigators will draw 0.1 mL of colostrum from each bag and tightly cap the needle hubs to ensure hygiene and safety. Each syringe will be labeled with the hospitalization number, the infant's name, and the date of the mother's colostrum expression. The bags will be then left to sit at room temperature for 5 min to reach an appropriate temperature for oropharyngeal administration of the colostrum. Subsequently, the tip and cap of the first syringe will be removed, and the colostrum will be slowly injected along the right oral mucosa of the participants, lasting at least 20 s. After injection, a sterile cotton swab will be used to gently wipe the right buccal mucosa for at least 10 s.
Normal SalineOther
For the control group, normal saline will be used instead of colostrum. The rest of the procedure will be the same as that for the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Colostrum Oropharyngeal Immunotherapy | Experimental | The study population will be randomly assigned to either the oropharyngeal colostrum administration group or the normal saline administration group. The intervention will commence within 48-72 h of birth and will be administered continuously for a duration of 5 days, with stool samples collected from the preterm infants before and after the intervention. Receives: Other: Colostrum |
| oropharyngeal normal saline administration | Placebo comparator | The study population will be randomly assigned to either the oropharyngeal colostrum administration group or the normal saline administration group. The normal saline administration will commence within 48-72 h of birth and will be administered continuously for a duration of 5 days, with stool samples collected from the preterm infants before and after thenormal saline administration. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of extrauterine growth restriction (EUGR) among participants at the time of hospital discharge
EUGR is defined as the situation where the growth measurement (weight, head circumference, or body length) taken at the time of discharge is less than or equal to the 10th percentile of the predicted value based on the Fenton 2013 growth chart.
Measured: The time frame extends from the first day of hospitalization to the day of discharge, covering the entire inpatient stay, with an average duration of 1.5 months.
Secondary outcomes (3)
The inter-group variances in the gut microbiota of participants subsequent to the intervention
The inter - group variances in alpha diversity of the gut microbiota between the colostrum - treated group and the placebo - treated group after the intervention
Measured: The seventh day after birth
Intergroup difference in the time to regain birth weight
The time to regain birth weight is an easily overlooked variable in the nutritional management of preterm infants. Previous studies have shown a significant linear relationship between the time to regain birth weight and the growth of very preterm infants after birth. Combining the factors of gestational age and birth weight can better reflect the growth of preterm infants after birth and a nutritional evaluation index for a Neonatal Intensive Care Unit.
Measured: Up to 10 days, with an average of 5 days.
The incidence rate of bronchopulmonary dysplasia
Bronchopulmonary dysplasia (BPD) is a chronic lung disease that predominantly affects premature infants, especially those with extremely low birth weights or those who have experienced severe respiratory distress syndrome shortly after birth. It represents a significant complication in neonatal intensive care units and has long - term implications for the respiratory health and overall development of affected infants. Here, BPD is defined as the need for oxygen or respiratory support at the corrected gestational age of 36 weeks.
Measured: The time frame extends from the first day of hospitalization to the day of discharge, covering the entire inpatient stay, with an average duration of 1.5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Sep 2028 (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 Growth FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suqian First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Na Wang, Suqian First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082881
- Sponsor's protocol ID
- suqianFH
- Acronym
- IOCOIOPGIPI
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang N, Hu Y, Qiu W, He M, Zang Q, Wang B, Tang B, Zhang H, Ni P, Zhu S, Zhang J. Impact of colostrum oropharyngeal immunotherapy on postnatal growth in preterm infants based on early gut microbiota-host interaction patterns: protocol for a randomized controlled trial. Int Breastfeed J. 2025 Sep 29;20(1):72. doi: 10.1186/s13006-025-00769-7.
PubMed 41024070
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Colostrum Oropharyngeal Immunotherapy on Postnatal Growth in Preterm Infants Based on Early Gut Microbiota-Host Interaction Patterns: A Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07082881
- Acronym / sponsor ID
- IOCOIOPGIPI / suqianFH
- Conditions
- Growth Failure, Preterm Birth, Microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Suqian First HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 24 Jul 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.
The goal of this clinical trial is to ascertain whether oropharyngeal administration of colostrum contributes to postnatal growth in very preterm infants (those born before 32 weeks of gestation). The main questions it aims to answer are:
Can Oropharyngeal administration of colostrum effectively lower the incidence rate of extrauterine growth restriction (EUGR) in participants? Does oropharyngeal colostrum intervention bring about changes in the early gut microbiota of participants? Researchers will conduct a comparative analysis between colostrum and a placebo (normal saline) to investigate whether oropharyngeal administration of colostrum has a beneficial effect on the postnatal growth of participants.
Participants will:
Initiation of oropharyngeal colostrum administration will take place within 48 - 72 hours after birth, and the treatment will be administered continuously for a period of 5 days.
Stool samples will be collected from the participants both before and after the intervention.
Participants will be required to maintain a diary to document their basic characteristics and clinical outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colostrum Oropharyngeal Immunotherapy | Experimental | Other: ColostrumThe study population will be randomly assigned to either the oropharyngeal colostrum administration group or the normal saline administration group. The intervention will commence within 48-72 h of birth and will be administered continuously for a duration of 5 days, with stool samples collected from the preterm infants before and after the intervention. |
| oropharyngeal normal saline administration | Placebo comparator | Other: Normal SalineThe study population will be randomly assigned to either the oropharyngeal colostrum administration group or the normal saline administration group. The normal saline administration will commence within 48-72 h of birth and will be administered continuously for a duration of 5 days, with stool samples collected from the preterm infants before and after thenormal saline administration. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age <32 weeks and birth weight <1500 g;
- admitted to the NICU of one of the five hospitals mentioned above within 24 h of birth; and
- able to initiate the protocol within 72 h of birth and continuously provide adequate colostrum until the end of the protocol.
Key exclusion criteria (5 listed)
- Death within 48 h;
- severe birth asphyxia (defined as umbilical artery/first-hour arterial blood gas pH < 7.0);
- birth with severe gastrointestinal malformations (e.g., intestinal atresia, tracheoesophageal fistula, malrotation of the intestines, and Hirschsprung's disease);
- prenatal diagnosis of congenital chromosomal abnormalities or suspected congenital genetic metabolic diseases; and
- maternal substance abuse or contraindications to breastfeeding (e.g., HIV).
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 |
|---|---|---|
| ColostrumThe treatment group will undergo the following treatment protocol within the initial 48-72 h: Investigators will select storage bags with the closest lactation time to the current time while wearing sterile gloves for the entire procedure. Next, using two 1-mL sterile syringes, investigators will draw 0.1 mL of colostrum from each bag and tightly cap the needle hubs to ensure hygiene and safety. Each syringe will be labeled with the hospitalization number, the infant's name, and the date of the mother's colostrum expression. The bags will be then left to sit at room temperature for 5 min to reach an appropriate temperature for oropharyngeal administration of the colostrum. Subsequently, the tip and cap of the first syringe will be removed, and the colostrum will be slowly injected along the right oral mucosa of the participants, lasting at least 20 s. After injection, a sterile cotton swab will be used to gently wipe the right buccal mucosa for at least 10 s. | Other | Colostrum Oropharyngeal Immunotherapy |
| Normal SalineFor the control group, normal saline will be used instead of colostrum. The rest of the procedure will be the same as that for the treatment group. | Other | oropharyngeal normal saline administration |
Primary outcome
The incidence rate of extrauterine growth restriction (EUGR) among participants at the time of hospital discharge
Time frame: The time frame extends from the first day of hospitalization to the day of discharge, covering the entire inpatient stay, with an average duration of 1.5 months.
EUGR is defined as the situation where the growth measurement (weight, head circumference, or body length) taken at the time of discharge is less than or equal to the 10th percentile of the predicted value based on the Fenton 2013 growth chart.
3 secondary outcomes
The inter-group variances in the gut microbiota of participants subsequent to the intervention
Time frame: The seventh day after birth
Intergroup difference in the time to regain birth weight
Time frame: Up to 10 days, with an average of 5 days.
The incidence rate of bronchopulmonary dysplasia
Time frame: The time frame extends from the first day of hospitalization to the day of discharge, covering the entire inpatient stay, with an average duration of 1.5 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 24 Jul 2025.
- Derived from this study: PubMed 41024070Wang N, Hu Y, Qiu W, He M, Zang Q, Wang B, Tang B, Zhang H, Ni P, Zhu S, Zhang J. Impact of colostrum oropharyngeal immunotherapy on postnatal growth in preterm infants based on early gut microbiota-host interaction patterns: protocol for a randomized controlled trial. Int Breastfeed J. 2025 Sep 29;20(1):72. doi: 10.1186/s13006-025-00769-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Colostrum and Normal Saline in people with Growth Failure and Preterm Birth, run by Suqian First Hospital.
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 5 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
The incidence rate of extrauterine growth restriction (EUGR) among participants at the time of hospital discharge (time frame: The time frame extends from the first day of hospitalization to the day of discharge, covering the entire inpatient stay, with an average duration of 1.5 months.). 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 NCT07082881, 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 24 Jul 2025.