NCT04826978

Brief Summary

Data on parent-infant physical closeness and infants' auditory environment will be collected among preterm infants when they are at gestational age of 32 to 34 weeks. The follow-up includes eye-tracker test at 7 months of corrected age for face preferences of the infants and simultaneously parents' eye movements and pupil diameter responses. During the second year, the follow up includes MacArthur Communicative Development Inventories (lexical development) at 12 and 24 months of age; language development test (Reynell Developmental Language Scales III) and developmental test (Bayley Scales for Infant development Edition III) at 24 months of corrected age.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

6.2 years

First QC Date

March 29, 2021

Last Update Submit

April 29, 2021

Conditions

Infant DevelopmentPreterm BirthLanguage Development

Keywords

Preterm infantNeonatal intensive careAuditory environmentParent-infant closenessSocial developmentCognitive developmentEye tracker

Outcome Measures

Primary Outcomes (6)

  • Face recognition by the infant

    Infants' focusing on parent faces will be measured by using a portable Tobii X2-60 eye-tracker or equivalent (Tobii Technology, Stockholm). The recording is based on a Pupil Centre Corneal Reflection (PCCR) technique.

    7 months of corrected age

  • Expressive language development

    Reynell Developmental Language Scales III

    24 months of corrected age

  • Receptive language development

    The long form version of the Communicative Development Inventories

    12 to 24 months of corrected age

  • Bayley Scales of Infant Development-III, cognitive scale

    A higher score indicates better cognitive development, no set minimum or maximum values, test norm population average is 100.

    24 months of corrected age

  • Physiological parents' saccadic reaction time

    Attention will be assessed as the mean saccadic reaction time in milliseconds to the location of own-child face.

    At 7 months of infant's corrected age

  • Physiological pupil responses to infant faces

    Pupil dilation will be assessed as pupil diameter in millimetres to face stimuli.

    At 7 months of infant's corrected age

Interventions

Auditory environmentBEHAVIORAL

Auditory environment

Eligibility Criteria

Age1 Week - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

63 preterm infants with their parents were recruited from the NICU of Turku University Hospital and 53 preterm infants with their parents from the NICU of Tallinn Children's Hospital in 1/2017-12/2020.

You may qualify if:

  • Born before 32+0 week of gestation

You may not qualify if:

  • Life-threatening diseases, congenital anomalies or syndromes or chromosomal abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Aija A, Stahlberg-Forsen E, Toome L, Aarnos L, Ahlqvist-Bjorkroth S, Stolt S, Lehtonen L. Parents' Speech in the NICU and Language Development of Very Preterm Children at 12 and 24 Months. J Pediatr Clin Pract. 2025 Jun 12;17:200156. doi: 10.1016/j.jpedcp.2025.200156. eCollection 2025 Sep.

    PMID: 40636560DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Liisa Lehtonen, MD

    University of Turku

    PRINCIPAL INVESTIGATOR

  • Suvi Stolt, PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

January 1, 2017

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

May 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share