Infant, Very Low Birth WeightNCT02389478
Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants
A study testing Oropharyngeal administration of colostrums and Oropharyngeal administration of Normal saline in people with Infant, Very Low Birth Weight, run by Children's Hospital of Fudan University.
Trial summary
The purpose of this study is to explore the effects of Oropharyngeal administration of colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the protect immune function of colostrum to very low birth weight infants, to improve the utilization of breast milk and reduce infection rates… Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Infant, Very Low Birth Weight
- What is being tested?
- Oropharyngeal administration of colostrums and Oropharyngeal administration of Normal saline
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Oct 2015
- 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 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born weight≤1500g
- transferred to our hospital within 24 hours after birth
- the mother can provide colostrum
- parents of the infants agreed to participate in this study
Who cannot join
- The infants suffering from life-threatening conditions ,such as severe heart disease,whose survival time are expected <30d
- The infants suffering from any kinds of disease,which impact they take human milk by mouth.(such as gastrointestinal malformations, NEC, etc.）
- human milk is contraindicated
- An infant whose mother :
- Is infected with the human immunodeficiency virus (HIV)
- Is taking antiretroviral medications
Show all 13Show fewer
- Has untreated active tuberculosis
- Is infected with human T-cell lymphotropic virus type l or ll
- Is using or dependent on an illicit drug except if the breastmilk is medically indicated
- Is taking prescribed cancer chemotherapy agents contraindicated for breastfeeding
- Is receiving any medications contraindicated in breast feeding
- Is receiving diagnostic or therapeutic radioactive isotopes or exposure to radioactive materials (for as long as they are radioactive in the milk)
- An infant diagnosed with galactosemia, a rare genetic metabolic disorder
About this study
Official title: Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants：Effects on Secretory Immunoglobulin A
The purpose of this study is to explore the effects of Oropharyngeal administration of colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the protect immune function of colostrum to very low birth weight infants, to improve the utilization of breast milk and reduce infection rates of very low birth weight infants.
Read the detailed description
The number of very low born weight infants increased every year.they are suffer from many questions.Recent studies have shown that Oropharyngeal administration of colostrum to very low birth weight infants can reduce the time reach full enteral nutrition .But there are no evidence support that it can promote infants' immune response. The hypothesis of the current study is that Oropharyngeal administration of colostrum to very low birth weight infants may increase the secretion of sIgA in urine and saliva.
The current study adopts randomized, double blind, controlled intervention trial, gives Oropharyngeal administration of colostrums to very low birth weight infants in intervention group and Oropharyngeal administration of Normal saline to control group. All indicators in this study are discrete traits, for sIgA、Lactoferrin number in Saliva and urine， number of CRP，time Begin oral feeding，time up to full enteral feeding， Person's chi-square tests were used for comparisons. For Blood culture results，The number of necrotizing enterocolitis (NEC) occurred， the investigators use Chi-square tests for comparisons between two groups. The study expects that Oropharyngeal administration of colostrum to very low birth weight infants can increase the secretion of sIgA in urine and saliva.
- Conditions
- Infant, Very Low Birth Weight
- Being tested
- Oropharyngeal administration of colostrums, Oropharyngeal administration of Normal saline
- Keywords
- oropharyngeal, breastmilk, colostrum, human milk, premature infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oropharyngeal administration of colostrumsProcedure or surgery
Also called oral immune therapy
rubbing drops of colostrum inside a baby's cheeks using a sterile syringe
Oropharyngeal administration of Normal salineProcedure or surgery
rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe
| Study group | Role | What they receive |
|---|---|---|
| colostrums | Experimental | Oropharyngeal administration of colostrums, every 4 hours，continue for 7days Receives: Procedure: Oropharyngeal administration of colostrums |
| Normal saline | Other | Oropharyngeal administration of Normal saline,every 4 hours，continue for 7days Receives: Procedure: Oropharyngeal administration of Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in sIgA at 7 days
in urine and saliva
Measured: at baseline（first time baby in hospital） and at 7 days
Change from Baseline in lactoferrin at 7 days
in urine and saliva
Measured: at baseline（first time baby in hospital） and at 7 days
Change from Baseline in sIgA at 21 days
in urine and saliva
Measured: at baseline（first time baby in hospital） and at 21 days
Change from Baseline in lactoferrin at 21 days
in urine and saliva
Measured: at baseline（first time baby in hospital） and at 21 days
Secondary outcomes (3)
The duration from admission to the start of oral feeding
when the first time participants start bottle feeding by mouth（>5ml/once）
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
The duration from the start of enteric feeding to full enteric feeding
when the volume of milk participants take by mouth up to 140ml/kg/day
Measured: participants will be followed for the duration of hospital stay, an expected average of 14 days
The number of participants with necrotizing enterocolitis (NEC)
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionOct 2015
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 Infant, Very Low Birth WeightStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Zhang YuXia, doctor, Study chair, Children Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389478
- Sponsor's protocol ID
- FNF201421
- Status last verified
- Nov 2015
- First submitted
- 8 Feb 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rodriguez NA, Meier PP, Groer MW, Zeller JM. Oropharyngeal administration of colostrum to extremely low birth weight infants: theoretical perspectives. J Perinatol. 2009 Jan;29(1):1-7. doi: 10.1038/jp.2008.130. Epub 2008 Sep 4.
PubMed 18769379
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants：Effects on Secretory Immunoglobulin A
- ClinicalTrials.gov ID
- NCT02389478
- Acronym / sponsor ID
- FNF201421
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- oropharyngeal, breastmilk, colostrum, human milk, premature infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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 purpose of this study is to explore the effects of Oropharyngeal administration of colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the protect immune function of colostrum to very low birth weight infants, to improve the utilization of breast milk and reduce infection rates of very low birth weight infants.
Detailed description
The number of very low born weight infants increased every year.they are suffer from many questions.Recent studies have shown that Oropharyngeal administration of colostrum to very low birth weight infants can reduce the time reach full enteral nutrition .But there are no evidence support that it can promote infants' immune response. The hypothesis of the current study is that Oropharyngeal administration of colostrum to very low birth weight infants may increase the secretion of sIgA in urine and saliva.
The current study adopts randomized, double blind, controlled intervention trial, gives Oropharyngeal administration of colostrums to very low birth weight infants in intervention group and Oropharyngeal administration of Normal saline to control group. All indicators in this study are discrete traits, for sIgA、Lactoferrin number in Saliva and urine， number of CRP，time Begin oral feeding，time up to full enteral feeding， Person's chi-square tests were used for comparisons. For Blood culture results，The number of necrotizing enterocolitis (NEC) occurred， the investigators use Chi-square tests for comparisons between two groups. The study expects that Oropharyngeal administration of colostrum to very low birth weight infants can increase the secretion of sIgA in urine and saliva.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colostrums | Experimental | Procedure: Oropharyngeal administration of colostrumsOropharyngeal administration of colostrums, every 4 hours，continue for 7days |
| Normal saline | Other | Procedure: Oropharyngeal administration of Normal salineOropharyngeal administration of Normal saline,every 4 hours，continue for 7days |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Born weight≤1500g
- transferred to our hospital within 24 hours after birth
- the mother can provide colostrum
- parents of the infants agreed to participate in this study
Key exclusion criteria (13 listed)
- The infants suffering from life-threatening conditions ,such as severe heart disease,whose survival time are expected <30d
- The infants suffering from any kinds of disease,which impact they take human milk by mouth.(such as gastrointestinal malformations, NEC, etc.）
- human milk is contraindicated
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 |
|---|---|---|
| Oropharyngeal administration of colostrumsAlso: oral immune therapyrubbing drops of colostrum inside a baby's cheeks using a sterile syringe | Procedure or surgery | colostrums |
| Oropharyngeal administration of Normal salinerubbing drops of Normal saline inside a baby's cheeks using a sterile syringe | Procedure or surgery | Normal saline |
Primary outcome
Change from Baseline in sIgA at 7 days
Time frame: at baseline（first time baby in hospital） and at 7 days
in urine and saliva
Change from Baseline in lactoferrin at 7 days
Time frame: at baseline（first time baby in hospital） and at 7 days
in urine and saliva
Change from Baseline in sIgA at 21 days
Time frame: at baseline（first time baby in hospital） and at 21 days
in urine and saliva
Change from Baseline in lactoferrin at 21 days
Time frame: at baseline（first time baby in hospital） and at 21 days
in urine and saliva
3 secondary outcomes
The duration from admission to the start of oral feeding
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
The duration from the start of enteric feeding to full enteric feeding
Time frame: participants will be followed for the duration of hospital stay, an expected average of 14 days
The number of participants with necrotizing enterocolitis (NEC)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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 10 Nov 2015.
- Background: PubMed 18769379Rodriguez NA, Meier PP, Groer MW, Zeller JM. Oropharyngeal administration of colostrum to extremely low birth weight infants: theoretical perspectives. J Perinatol. 2009 Jan;29(1):1-7. doi: 10.1038/jp.2008.130. Epub 2008 Sep 4.
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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.
Zhang YuXia, doctor study chair
Children Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing Oropharyngeal administration of colostrums and Oropharyngeal administration of Normal saline in people with Infant, Very Low Birth Weight, run by Children's Hospital of Fudan University.
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 13 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 10 Nov 2015. 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. 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?
Change from Baseline in sIgA at 7 days (time frame: at baseline（first time baby in hospital） and at 7 days). The study lists 4 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 NCT02389478, 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 10 Nov 2015.