UMIN-CTR Clinical Trial

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
Email	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
Email	wxy-kk@hotmail.co.jp

Sponsor
Institute	Okayama University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026416