ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000021153
Date of registration:	01/08/2016
Prospective Registration:	No
Primary sponsor:	St. Luke's International Hospital
Public title:	Activity and sleep assessment of preterm infants
Scientific title:	Activity and sleep assessment of preterm infants - Activity and Sleep Assessment of Preterms (ASAP)
Date of first enrolment:	2013/06/01
Target sample size:	25
Recruitment status:	Recruiting
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016741
Study type:	Observational
Study design:	Not selected Not selected
Phase:	Phase I

Countries of recruitment
Japan

Contacts

Name:	Isao Kusakawa
Address:	Akashi-cho 9-1,Chuou-ku,Tokyo Japan
Telephone:	03-3541-5151
Email:	isaokusa@luke.ac.jp
Affiliation:	St. Luke's International Hospital Pediatrics

Name:	Machiko Nakagawa
Address:	Akashi-cho 9-1,Chuou-ku,Tokyo Japan
Telephone:	03-3541-5151
Email:	machina@luke.ac.jp
Affiliation:	St. Luke's International Hospital Pediatrics

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: (1) Severe illness or congenital abnormality. (2) Use of infant medication with sedative effects.

Age minimum: 1years-old
Age maximum: 4years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

preterm infants

Intervention(s)

Primary Outcome(s)

sleep efficieney

Secondary Outcome(s)

WASO (wake after sleep onset) sleep onset time daytime activity nighttime sleep duration developmental quotient

Secondary ID(s)

Source(s) of Monetary Support

St. Luke's Life Science Institute

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.