UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022923 |
|---|---|
| Receipt number | R000026416 |
| Scientific Title | The effect of oropharyngeal colostrum administration in preterm infants |
| Date of disclosure of the study information | 2016/06/29 |
| Last modified on | 2020/07/01 10:55:52 |
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Basic information
Public title
The effect of oropharyngeal colostrum administration in preterm infants
Acronym
The effect of oropharyngeal colostrum administration in preterm infants
Scientific Title
The effect of oropharyngeal colostrum administration in preterm infants
Scientific Title:Acronym
The effect of oropharyngeal colostrum administration in preterm infants
Region
| Japan |
Condition
Condition
preterm infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate longitudinal change of Reactive oxygen metabolite and Biological anti-oxygen potential of preterm infants with oropharyngeal colostrum administration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reactive oxygen metabolite, Biological anti-oxygen potential of day3(before colostrum administration), 7(after colostrum administration), 14
Key secondary outcomes
length of accomplishment of enteral alimentation(>100ml/kg/day), body weight gain, length of hospitalization, carriage rate of MRSA, prevalence of septicemia, serum IgA
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Attending physician explains about this research to the parents at birth. After written informed consent is obtained, each neonate is randomly assigned to the colostrum or placebo group in a 1:1 ratio. Obstetric nurse meet the mothers of each enrolled neonate within 24 hours after birth to educate about milking stimulus, and how to get breast milk aseptically. One unblinded investigator who does not care neonates directly prepares 40 syringes with 0.2ml of mother's colostrum using aseptic techniques. Then syringes are labeled, covered with opaque tape, placed in prelabeled cups and stored at 4degrees Celsius in refrigerator for exclusive use. Oropharyngeal colostrum administration begins at 72 hours after birth, each neonate receives 0.2ml of colostrum or sterile water every 3 hours for 120 consecutive hours, without relation of whether the feeding start enterally. Before administration, prefilled syringe with 0.2 ml of colostrum is warmed in the infant's incubator for 5 minutes. Nurse places the syringe on the patient's right or left buccal mucosa, and administer the colostrum toward the posterior oropharynx slowly (for at least 10 seconds).Pulse oxygen saturation, respiratory rate, pulse rate, and blood pressure changes and frequency of apnea are recorded before and after intervention to detect complications. A intervention is discontinued if any of the following issues developed: desaturation which requires increase in oxygen supply, bradycardia (HR.100/minute) or tachycardia (HR.200/minute), and tachypnea (RR.80/minute). We obtain blood samples before(day3) and after(day7) administration and day14, and evaluate longitudinal change of IgA, Reactive oxygen metabolite, Biological anti-oxygen potential. We will also evaluate change of body weight gain, length of hospitalization, carriage rate of MRSA, prevalence of septicemia. Measurement of Reactive oxygen metabolite and Biological anti-oxygen potential are conducted by using FREE CARRIO DUO.
Interventions/Control_2
Attending physician explains about this research to the parents at birth. After written informed consent is obtained, each neonate is randomly assigned to the colostrum or placebo group in a 1:1 ratio. The placebo group is administered sterile water. One unblinded investigator who does not care neonates directly prepares 40 syringes with 0.2ml of sterile distilled water using aseptic techniques. Then syringes are labeled, covered with opaque tape, placed in prelabeled cups and stored at 4 degrees Celsius in refrigerator for exclusive use. Oropharyngeal administration begins at 72 hours after birth, each neonate receive 0.2ml of colostrum or sterile water every 3 hours for 120 consecutive hours, without relation of whether the feeding started enterally. Before administration, prefilled syringe with 0.2 ml of sterile water is warmed in the infant's incubator for 5 minutes. Nurse places the syringe on the patient's right or left buccal mucosa, and administers the colostrum or placebo toward the posterior oropharynx slowly (for at least 10 seconds). Pulse oxygen saturation, respiratory rate, pulse rate, and blood pressure changes and frequency of apnea are recorded before and after intervention to detect complications. A intervention is discontinued if any of the following issues developed: desaturation which requires increase in oxygen supply, bradycardia (HR .100/minute) or tachycardia (HR .200/minute), and tachypnea (RR .80/minute). We obtain blood samples before(day3) and after(day7) administration and day14, and evaluate longitudinal change of IgA, Reactive oxygen metabolite, Biological anti-oxygen potential. We will also evaluate change of body weight gain, length of hospitalization, carriage rate of MRSA, prevalence of septicemia. Measurement of Reactive oxygen metabolite and Biological anti-oxygen potential are conducted by using FREE CARRIO DUO.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | days-old | <= |
Age-upper limit
| 3 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Neonates born before 32 weeks gestation in our NICU are enrolled.
Key exclusion criteria
Infants meet the exclusion criteria which is discribed below are excluded
1.Infant who can't obtain colostrum within 72hours
2.Infants with congenital malformations
3.Infants with chromosomal abnormalities
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Washio |
Organization
Okayama University hospital
Division name
Pediatrics
Zip code
700-8558
Address
2-5-1,Shikatacho, Kitaku Okayamcity, Okayama, 700-8558, Japan
TEL
086-235-7902
wxy-kk@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Washio |
Organization
Okayama University hospital
Division name
Pediatrics
Zip code
700-8558
Address
2-5-1,Shikatacho, Kitaku Okayamcity, Okayama, 700-8558, Japan
TEL
086-235-7902
Homepage URL
wxy-kk@hotmail.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University hospital
Address
2-5-1,Shikatacho, Kitaku Okayamcity, Okayama, 700-8558, Japan
Tel
086-2237151
wxy-kk@hotmail.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2015 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 28 | Day |
Last modified on
| 2020 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026416
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| Registered date | File name |
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