Extremely Low Gestational Age NewbornPhase 2NCT01536093
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
A Phase 2 study testing oropharyngeal administration of own mother's colostrum and oropharyngeal administration of sterile water in people with Extremely Low Gestational Age Newborn and Premature Infant, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants. However, most of them could not proceed enteral feedings due to clinical instability in the first few days. Read more about this study
- Who is it for?
- Ages 48 to 96 hoursHealthy volunteers can take part
- Conditions the study is for
- Extremely Low Gestational Age Newborn, Premature Infant
- What is being tested?
- oropharyngeal administration of own mother's colostrum and oropharyngeal administration of sterile water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 48 to 96 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- premature infant with a gestational age less than 28 weeks born at Seoul National University Hospital and admit to the Seoul National University Children's Hospital NICU immediately after birth
- parents of the infant signed to the informed consent form with voluntary agreement
Who cannot join
- infants with major congenital anomalies or chromosomal syndromes
- infants of mothers not willing to provide colostrum in the first week of life
- infants of mothers with known infectious diseases that may be transmitted through the breast milk such as HIV, hepatitis C or active TB
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, 110-744
About this study
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants. However, most of them could not proceed enteral feedings due to clinical instability in the first few days. Recent studies supports oropharyngeal administration as a potentially safe and effective delivery method for immunologic benefits and only small amount of colostrum could be administrated for immune therapy for extremely premature babies. The purpose of this study is to determine the beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in extremely low gestational age infants and evaluated the safety of this method to extremely premature infants in the first few days of life.
- Being tested
- oropharyngeal administration of own mother's colostrum, oropharyngeal administration of sterile water
- 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 own mother's colostrumOther
application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
oropharyngeal administration of sterile waterOther
application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
| Study group | Role | What they receive |
|---|---|---|
| Colostrum | Experimental | oropharyngeal administration of own mother's colostrum Receives: Other: oropharyngeal administration of own mother's colostrum |
| Placebo | Placebo comparator | oropharyngeal administration of sterile water Receives: Other: oropharyngeal administration of sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Secretary IgA Concentration at 2 Weeks of Age
Measured: 2 weeks of age
Secondary outcomes (16)
Urinary Secretary IgA Concentration at 1 Week of Age
Measured: 1 week of age
Salivary TGF-beta 1 Concentration at 2 Week of Age
Measured: 2 week of age
Salivary IL-8 Concentration at 2 Weeks of Age
Measured: 2 weeks of age
Concentration of Urinary Lactoferrin
Measured: 1 week of age
Concentration of Urinary IL-1 Beta
Measured: 2 weeks of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
Measured: 1 week of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
Measured: 2 weeks of age
Time to Reach Full Feeding
day of life when the baby reaches full enteral feeding, defined as a volume above 120~130mL/kg/day
Measured: up to 2 months of age
Total Hospital Admission Duration
days from admission to discharge from NICU
Measured: up to 4 months of age
Episodes of Culture Positive Sepsis
numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)
Measured: from date of randomization up to 4 months of age
Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2
Measured: from date of randomization up to 4 months of age
Episodes of Pneumonia
numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics
Measured: from date of randomization up to 4 months of age
Development of Bronchopulmonary Dysplasia ≥ Moderate
Measured: up to 4 months of age
Development of Intraventricular Hemorrhage ≥ Grade 3
Measured: up to 4 months of age
In-hospital Death
Measured: up to 4 months of age
Development of Adverse Effects
category of adverse effects
- general - fever or hypothermia, rash
- respiratory \& cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia
- gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis
- renal - oliguria (urine output < 1.0cc/kg/day)
- laboratory - hypo-/hyper-natremia, acidosis, hypercarbia
Measured: from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extremely Low Gestational Age NewbornStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Suk Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536093
- Sponsor's protocol ID
- OAC-01-ELGAN
- Status last verified
- Aug 2014
- First submitted
- 6 Jan 2012
- Last updated
- 13 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lee J, Kim HS, Jung YH, Choi KY, Shin SH, Kim EK, Choi JH. Oropharyngeal colostrum administration in extremely premature infants: an RCT. Pediatrics. 2015 Feb;135(2):e357-66. doi: 10.1542/peds.2014-2004.
PubMed 25624376
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
- ClinicalTrials.gov ID
- NCT01536093
- Acronym / sponsor ID
- OAC-01-ELGAN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Posted 12 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants. However, most of them could not proceed enteral feedings due to clinical instability in the first few days. Recent studies supports oropharyngeal administration as a potentially safe and effective delivery method for immunologic benefits and only small amount of colostrum could be administrated for immune therapy for extremely premature babies. The purpose of this study is to determine the beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in extremely low gestational age infants and evaluated the safety of this method to extremely premature infants in the first few days of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colostrum | Experimental | Other: oropharyngeal administration of own mother's colostrumoropharyngeal administration of own mother's colostrum |
| Placebo | Placebo comparator | Other: oropharyngeal administration of sterile wateroropharyngeal administration of sterile water |
Who may qualify
- Ages
- 48 to 96 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- premature infant with a gestational age less than 28 weeks born at Seoul National University Hospital and admit to the Seoul National University Children's Hospital NICU immediately after birth
- parents of the infant signed to the informed consent form with voluntary agreement
Key exclusion criteria (3 listed)
- infants with major congenital anomalies or chromosomal syndromes
- infants of mothers not willing to provide colostrum in the first week of life
- infants of mothers with known infectious diseases that may be transmitted through the breast milk such as HIV, hepatitis C or active TB
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 own mother's colostrumapplication of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours. | Other | Colostrum |
| oropharyngeal administration of sterile waterapplication of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours. | Other | Placebo |
Primary outcome
Urinary Secretary IgA Concentration at 2 Weeks of Age
Time frame: 2 weeks of age
16 secondary outcomes
Urinary Secretary IgA Concentration at 1 Week of Age
Time frame: 1 week of age
Salivary TGF-beta 1 Concentration at 2 Week of Age
Time frame: 2 week of age
Salivary IL-8 Concentration at 2 Weeks of Age
Time frame: 2 weeks of age
Concentration of Urinary Lactoferrin
Time frame: 1 week of age
Concentration of Urinary IL-1 Beta
Time frame: 2 weeks of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
Time frame: 1 week of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
Time frame: 2 weeks of age
Time to Reach Full Feeding
Time frame: up to 2 months of age
Total Hospital Admission Duration
Time frame: up to 4 months of age
Episodes of Culture Positive Sepsis
Time frame: from date of randomization up to 4 months of age
Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2
Time frame: from date of randomization up to 4 months of age
Episodes of Pneumonia
Time frame: from date of randomization up to 4 months of age
Development of Bronchopulmonary Dysplasia ≥ Moderate
Time frame: up to 4 months of age
Development of Intraventricular Hemorrhage ≥ Grade 3
Time frame: up to 4 months of age
In-hospital Death
Time frame: up to 4 months of age
Development of Adverse Effects
Time frame: from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25624376Lee J, Kim HS, Jung YH, Choi KY, Shin SH, Kim EK, Choi JH. Oropharyngeal colostrum administration in extremely premature infants: an RCT. Pediatrics. 2015 Feb;135(2):e357-66. doi: 10.1542/peds.2014-2004.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oropharyngeal administration of own mother's colostrum and oropharyngeal administration of sterile water in people with Extremely Low Gestational Age Newborn and Premature Infant, run by Seoul National University Hospital at 1 site in South Korea.
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 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 13 Aug 2014. 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 South Korea. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Urinary Secretary IgA Concentration at 2 Weeks of Age (time frame: 2 weeks of age). 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 NCT01536093, 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 Aug 2014.