Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent

Parents Clinical Trial

Official title:

Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05334550
• Other study ID #: 2022-02-28
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: March 2, 2024

Study information

• Verified date: June 2022
• Source: Samsung Medical Center
• Contact: Lee Jinuk, resident
• Phone: +8210-4555-3349
• Email: jinuk8780.lee[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent.

Description:

The perpose of this study to prove the significance of the hypothesis that there will be a significant improvement in motor development when remote tele-rehabilitation treatment is performed for extremely premature infants. The investigators plan to recruit subjects who meet the inclusion criteria and do not meet the exclusion criteria from among extremely premature infants born at Samsung Hospital, Seoul, Korea, whose gestational age is from 23 weeks to 28 weeks. The target number of n is 110, 55 per group. After randomization into an intervention group and a control group, the intervention group get the intervention starting at 0 months of correctional age and runs for 3 months. In both groups, motor outcomes are measured at the time of enrollment, at 3 months of correction age, 6 months of correction age and 12 months of correction age

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: March 2, 2024
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Extreme premature baby (gestationl age 23~28 weeks)

• Corrected age under one month at the time of enroll of this study

• Children of those who voluntarily decided to participate after hearing detailed explanations about this study and gave their written consent.

• Children whose parents are Korean

Exclusion Criteria:

• Congenital anomalies in the central nervous system

• Hereditary diseases

• Chromosomal abnormalities (Down syndrome, etc.)

• Stage 3 or more intraventricular hemorrhage

• If surgery was performed for hydrocephalus

• Leukomalacia confirmed by ultrasound examination (not applicable to increase in white matter shading)

• Neonatal asphyxia

• Other central nervous system diseases

• If taking medications for convulsions or epilepsy

• Metabolic disease

• In the case of premature infants undergoing surgery for retinal disease

• Hearing loss

• In case of surgery due to complex congenital anomaly or planned operation (not excluded if surgery is not required)

• In case of oxygen dependence due to lung disease in premature infants

• Musculoskeletal disorders (hip dislocation, polyarthrosis, etc.)

• Neuromuscular disease, etc.

• Those whose family has social problems

• Those whose parents cannot participate in this study

• Those who have other serious complications that cannot proceed with the study

Related Conditions & MeSH terms

• Developmental Delay
• Early Intervention
• Extreme Prematurity
• Home Exercise
• Parents
• Premature Birth
• Preterm

Intervention

Other:
• Home Based Early Intervention by Parent
Through a video communication program called ZOOM, the parents of intervention group are educated once every two weeks for three months. Parent education consists of a program developed by our pediatric rehabilitation therapist to help premature infants develop motor skills. Parents provide daily exercise training to their children as educated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

References & Publications (20)

???, ???. ???19, ??? ??? ?????. ??&?? . (2020): 1-26.

???, ?2019? ????(??), ?????? ?10103? ?????

Aita M, De Clifford Faugère G, Lavallée A, Feeley N, Stremler R, Rioux É, Proulx MH. Effectiveness of interventions on early neurodevelopment of preterm infants: a systematic review and meta-analysis. BMC Pediatr. 2021 Apr 29;21(1):210. doi: 10.1186/s12887-021-02559-6. — View Citation

Boyce P, Stubbs J, Todd A. The Edinburgh Postnatal Depression Scale: validation for an Australian sample. Aust N Z J Psychiatry. 1993 Sep;27(3):472-6. — View Citation

Campbell SK, Wright BD, Linacre JM. Development of a functional movement scale for infants. J Appl Meas. 2002;3(2):190-204. — View Citation

Clutterbuck GL, Auld ML, Johnston LM. High-level motor skills assessment for ambulant children with cerebral palsy: a systematic review and decision tree. Dev Med Child Neurol. 2020 Jun;62(6):693-699. doi: 10.1111/dmcn.14524. Epub 2020 Apr 1. — View Citation

Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. — View Citation

Fan J, Wang J, Zhang X, He R, He S, Yang M, Shen Y, Tao X, Zhou M, Gao X, Hu L. A home-based, post-discharge early intervention program promotes motor development and physical growth in the early preterm infants: a prospective, randomized controlled trial. BMC Pediatr. 2021 Apr 7;21(1):162. doi: 10.1186/s12887-021-02627-x. — View Citation

Fernández Rego Francisco Javier, Gómez Conesa Antonia, Pérez López Julio, Efficacy of Early Physiotherapy Intervention in Preterm Infant Motor Development- A Systematic Review-, Journal of Physical Therapy Science, 2012, Volume 24, Issue 9, Pages 933-940, Released December 01, 2012, Online ISSN 2187-5626, Print ISSN 0915-5287

Holloway JM, Long TM, Biasini F. Relationships Between Gross Motor Skills and Social Function in Young Boys With Autism Spectrum Disorder. Pediatr Phys Ther. 2018 Jul;30(3):184-190. doi: 10.1097/PEP.0000000000000505. — View Citation

Martin T. Stein, Meghan Korey Lukasik, Chapter 79 - DEVELOPMENTAL SCREENING AND ASSESSMENT: INFANTS, TODDLERS, AND PRESCHOOLERS, Editor(s): William B. Carey, Allen C. Crocker, William L. Coleman, Ellen Roy Elias, Heidi M. Feldman, Developmental-Behavioral Pediatrics (Fourth Edition), W.B. Saunders, 2009, Pages 785-796,

McIntire DD, Leveno KJ. Neonatal mortality and morbidity rates in late preterm births compared with births at term. Obstet Gynecol. 2008 Jan;111(1):35-41. doi: 10.1097/01.AOG.0000297311.33046.73. — View Citation

Milgrom J, Ericksen J, Negri L, Gemmill AW. Screening for postnatal depression in routine primary care: properties of the Edinburgh Postnatal Depression Scale in an Australian sample. Aust N Z J Psychiatry. 2005 Sep;39(9):833-9. — View Citation

Morgan AM, Koch V, Lee V, Aldag J. Neonatal neurobehavioral examination. A new instrument for quantitative analysis of neonatal neurological status. Phys Ther. 1988 Sep;68(9):1352-8. — View Citation

Piper MC, Darrah J. Motor Assessment of the Developing Infant. Philadelphia: WB Saunders; 1994.

Piper MC, Pinnell LE, Darrah J, Maguire T, Byrne PJ. Construction and validation of the Alberta Infant Motor Scale (AIMS). Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S46-50. — View Citation

Puthussery S, Chutiyami M, Tseng PC, Kilby L, Kapadia J. Effectiveness of early intervention programs for parents of preterm infants: a meta-review of systematic reviews. BMC Pediatr. 2018 Jul 9;18(1):223. doi: 10.1186/s12887-018-1205-9. — View Citation

Spittle A, Orton J, Anderson PJ, Boyd R, Doyle LW. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants. Cochrane Database Syst Rev. 2015 Nov 24;(11):CD005495. doi: 10.1002/14651858.CD005495.pub4. Review. — View Citation

Tavasoli A, Azimi P, Montazari A. Reliability and validity of the Peabody Developmental Motor Scales-second edition for assessing motor development of low birth weight preterm infants. Pediatr Neurol. 2014 Oct;51(4):522-6. doi: 10.1016/j.pediatrneurol.2014.06.010. Epub 2014 Jun 24. — View Citation

Wang M, Mei H, Liu C, Zhang Y, Huixian LI, Yan F. Application of the Peabody developmental motor scale in the assessment of neurodevelopmental disorders in premature infants. Chinese Pediatric Emergency Medicine. 2017 Jan 1;24(10):760-3.

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Test of infant motor performance at 3 months	The Test of infant motor performance (TIMP) is conducted on infants under 4 months of age to perform functions in daily life. It is performed to evaluate the selective control of postures and movements that infants need in daily life, and takes an average of 25-35 minutes. The TIMP was developed to 1) identify infants with delayed motor development, 2) differentiate between infants with varying degrees of risk for measurement outcomes, and 3) measure changes due to interventions. Because it can be used in both early intervention programs, it can aid in communication between parents and health care providers in a variety of settings. The range of test score is from 0 to 142. The higher score means the better motor performance.	around the start of intervention(up to 1 week), 3 months after the start of intervetion
Secondary	Change from baseline Edinburgh postnatal depression scale at 3 months	Edinburgh postnatal depression scale is a 10-item scale for screening for maternal depression. Each item is scored from 0 to 3; the higher score indicates the possibility of depressed status. Total score is from 0 to 30. A score of 13 or higher indicates a possible postpartum depression. It has been validated by several studies confirming that EPDS is a reliable and sensitive indicator of depression.	around the start of intervention(up to 1 week), 3 months after the start of intervetion
Secondary	Alberta infant motor scale	Alberta infant motor scale is a validated and reliable observational tool for use in infants from full term to 18 months of age. Alberta infant motor scale can evaluate the qualitative aspects of movement and sensitively measure the change in infant's motor performance. Assessment of Alberta infant motor scale is scored based on the number of gross motor postures and movements the infant has demonstrated while prone, supine, and sitting or standing. The range of scores of each item are as followed; prone is from 0 to 21, supine is from 0 to 9, sitting is from 0 to 12, standing is from 0 to 16. The range of total score is from 0 to 58. The higher score means the better motor performance. The evaluation score can be converted to a percentile rank that can be compared with the percentile rank of a standard age-matched infant sample.	6 months and 12 months after the start of intervetion
Secondary	Peabody Developmental Motor Scales 2nd edition	Peabody Developmental Motor Scales 2nd edition evaluates both fine motor and macromotor function. It can be evaluated from newborn to 5 years old. It consists of six subtests: reflex, stationary, locomotion, object manipulation, grasping, and visual motor integration. Range of score of each items are as followed; reflex is from 0 to 16, stationary is from 0 to 60, locomotion is from 0 to 198, objective manipulation is from 0 to 48, grasping is from 0 to 26, visual-motor integration is from 0 to 72. The summation of scores is converted into age-matched percentile that can be ranked. The higher scores is matched to better ranked percentile. Peabody Developmental Motor Scales 2nd edition is a test whose reliability and validity have been verified in various conditions such as autism, cerebral palsy, and premature infants.	12 months after the start of intervetion