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

NCT05334550 | Unknown

• 1 other identifier: 2022-02-28
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Preterm; Extreme Prematurity; Early Intervention; Developmental Delay; Motor Outcome; Home Exercise; Parents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline Edinburgh postnatal depression scale at 3 months

  around the start of intervention(up to 1 week), 3 months after the start of intervetion

• Alberta infant motor scale

  6 months and 12 months after the start of intervetion

• Peabody Developmental Motor Scales 2nd edition

  12 months after the start of intervetion

Study Arms (2)

Intervention group

EXPERIMENTAL

Allocated to intervention group through randomization process.

Other: Home Based Early Intervention by Parent

Control group

NO INTERVENTION

Allocated to control group through randomization process.

Interventions

Home Based Early Intervention by Parent OTHER

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Samsung Medical Center: lead

Related Publications (20)

• 통계청, 『2019년 출생통계(확정), 국가승인통계 제10103호 출생통계』

  BACKGROUND

• 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.

  PMID: 18165390 BACKGROUND

• 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. doi: 10.1093/ptj/68.9.1352.

  PMID: 3420169 BACKGROUND

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

  BACKGROUND

• Aita M, De Clifford Faugere G, Lavallee A, Feeley N, Stremler R, Rioux E, 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.

  PMID: 33926417 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 29986683 BACKGROUND

• 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;2015(11):CD005495. doi: 10.1002/14651858.CD005495.pub4.

  PMID: 26597166 BACKGROUND

• 배영임, 신혜리. 코로나19, 언택트 사회를 가속화하다. 이슈&진단 . (2020): 1-26.

  BACKGROUND

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

  PMID: 12011500 BACKGROUND

• 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. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• 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. doi: 10.3109/00048679309075805.

  PMID: 8250792 BACKGROUND

• 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. doi: 10.1080/j.1440-1614.2005.01660.x.

  PMID: 16168042 BACKGROUND

• 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.

  PMID: 1468050 BACKGROUND

• 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,

  BACKGROUND

• 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.

  PMID: 33827496 BACKGROUND

• 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.

  PMID: 29727358 BACKGROUND

• 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.

  PMID: 32237147 BACKGROUND

• 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.

  PMID: 25266615 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Premature Birth; Learning Disabilities

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kwon Jeong-Yi, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Jinuk, resident

CONTACT

+8210-4555-3349; jinuk8780.lee@samsung.com

Kwon Jeong-Yi, PhD

CONTACT

+82-2-3410-2818; jeongyi.kwon@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 19, 2022
• Study Start: June 2, 2022
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2024
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share