Infant DevelopmentAPPLENCT04826978
Auditory Environment by Parents of Preterm Infants
An observational study of Infant Development and Preterm Birth, run by Turku University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 week to 3 months
- Conditions the study is for
- Infant Development, Preterm Birth, Language Development
- What is being tested?
- Auditory environment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Mar 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 3 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Born before 32+0 week of gestation
Who cannot join
- Life-threatening diseases, congenital anomalies or syndromes or chromosomal abnormalities.
About this study
Official title: Auditory Environment by Parents of Preterm Infant; Language Development and Eye-movements
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.
Read the detailed description
Study population: 63 infants from Turku University Hospital and 53 infants from Tallinn Children's Hospital were recruited in 1/2017-12/2020. Inclusion criteria: Born before 32+0 week of gestation without life-threatening diseases or congenital anomalies or syndromes.
Infant auditory environment was recorded for 16 hours at 32+0 to 33+6 weeks of postmenstrual age. In addition, Parental Closeness Diary was recorded for 14 days to measure the parents' presence and parent-infant closeness to get an estimate of language environment of the child during a 14-day period at around 32-34 weeks of gestation. Edinburgh Postnatal Depression Scale was collected during the recording day from both parents to identify parents' risk for perinatal depression. During the day of recording, the research nurse reported the time when a nurse was in the patient room. The auditory environment will be analyzed quantitatively and qualitatively.
Outcomes: Infant face preference for familiar and unfamiliar faces. At the corrected age of 7 months (± 7 days), an eye-tracking based test battery will be used to assess infants' attention to familiar and unfamiliar faces. During the eye-tracking testing, the infants will sit on their parents' lap at ~60 cm distance from a stimulus monitor. Infants' eye movements will be measured by using a screen-based eye-tracker and a video camera.
The test will consist of a task assessing infants' attention to faces expressing neutral, happy and fearful emotion, posed by the infant's own parents and an unfamiliar (female) adult. In this task, the first stimulus (a non-face pattern or a face) is presented at the participant's point of fixation in the center of the computer display, and the second stimulus (a high-contrast distractor) 1 second later ~13-15° to the left or right of the center. Gaze disengagement times from the central to the lateral stimulus will be extracted from the eye tracking data (or from video data, if valid eye tracking data are missing). Disengagement times from trials conforming to the following a priori inclusion criteria will be used in the analyses: i) a sufficient length of fixation on the central stimulus (i.e.,70 % of the time) during the analysis period, which start at the onset of the trial and ends at the onset of gaze disengagement or at maximum time out value (1000 ms post-target), ii) sufficient number of valid samples in the gaze data (i.e., no gaps longer than 200 ms), and, iii) valid information about the eye movement from the central to the lateral stimulus (i.e., the eye movement did not occur during a period of missing gaze data) will be retained for analysis. The duration of attention dwell time on the first stimulus (face or non-face pattern) will be determined for the period starting 150 ms from the onset of the lateral stimulus and ending 1000 ms after the lateral stimulus onset. The duration will then be converted to a normalized dwell time index score by using the formula described in Leppänen et al. (2015). The shortest acceptable saccadic eye movement latency (150 ms) results in a dwell time score of 0, and the longest possible latency (or a lack of saccade, which is equal to the last measured time point of the first stimulus at 1000 ms) in a dwell time index score of 1. The dwell time indices will be calculated separately for each trial and averaged for non-face patterns (i.e., low-salience stimulus), for faces by familiarity (across emotion categories), and for faces by emotion category (across familiarity and separately by familiarity). The primary outcome of the analysis will be the mean dwell times for familiar and unfamiliar faces, adjusted for the mean dwell time for respective non-face patterns. All infants with >2 valid trials per condition will be retained in the final statistical analyses.
Parents' attention and physiological responses to infant faces. Parents attentional and physiological (i.e., pupil dilation) to non-face patterns and faces of their own infant(s) and unknown infants will be assessed at infant age 7 months. Parents will be asked to provide pictures of their own infant(s) prior to each laboratory visit. Pictures displaying positive/content and distressed emotions will be asked.
Picture from an existing dataset will be used as unknown infant pictures. Non-faced patterns will be created by phase-scrambling the pictures so that they retain the low-level characteristics of the original faces, but are not identifiable as faces.
To assess attention, the adults will be asked to follow (by looking) a geometric shape (a checkerboard pattern, measuring 2x2 degrees) as it shifts location from the center of the screen (500-msec) to the left or right side of the screen (~13 degrees from the center). After the participant has shifted gaze from the center to the side (as determined by the eye tracker), the pattern will be replaced by a picture of a non-face pattern or a face for 300-msec. The side of the non-face pattern and face (A= non-face left, face right or B= face left, non-face right) will be alternated between blocks of 20 trials following an ABBA-BAAB design. Using this approach, estimates of saccadic reaction times (SRTs) to the location of own infant face(s) vs. non-faces and two unknown infant faces vs non-face patterns. Because saccadic reaction times will always be initiated by the shifting location of the shape (a checkerboard pattern), any difference in mean SRT must reflect an endogenous or high-level bias towards one of the stimuli (e.g. own infant face), instead of exogenous stimulus properties. To extract attention indicators from the adult data, the latency of gaze shifts between the center of the screen and lateral stimulus positions (following shifts in stimulus position) will be analyzed by using the same procedures as those used for analyzing infant attentional data. To assess parents' sympathetic activation to infant cues, we will follow the procedures of our previous study (Yrttiaho et al., 2017). The adult will see a series of trials consisting of a short 1000-ms pre-stimulus interval with the non-face pattern and a 4000-ms face stimulus (own or unknown infant). Pupil size will be measured from both eyes during the pre-stimulus interval (with random visual pattern that has the same low-level stimulus characteristics as paired face stimulus) and the presentation of the face stimuli. By matching the low-level characteristics of the two consecutive stimuli, the present approach minimizes the possibility that the recorded pupil dilation responses are driven by changes in stimulus luminance. Latencies for each stimulus category will be extracted and used as a primary dependent variable in subsequent statistical analyses. Physiological data from adults (pupil diameter) will be preprocessed using the steps described in our previous study (Yrttiaho et al., 2017), and pupil diameter in two time windows (based on prior studies, these windows will be 300-1200 and 3000-4000 ms after face onset, respectively) will be averaged to extract of pupil constriction and dilation, respectively. The dilation phase will be used as the primary index of sympathetic arousal to infant distress cues.
Information about the child's developing abilities of early language (receptive and expressive language development) will be assessed by MacArthur-Bates Communicative Development Inventory (MCDI) at 12 and 24 months of corrected age.
At two years of corrected age the language skills of the children were measured using the Reynell Development Language Scales III and MacArthur Communicative Development Inventories (the Words and Sentences form). In addition, children's cognitive development was measured using the Bayley Scales of Infant Development III.
- Conditions
- Infant Development, Preterm Birth, Language Development
- Being tested
- Auditory environment
- Keywords
- Preterm infant, Neonatal intensive care, Auditory environment, Parent-infant closeness, Social development, Cognitive development, Eye tracker
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory environmentBehavioural
Auditory environment
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months of corrected age
Expressive language development
Reynell Developmental Language Scales III
Measured: 24 months of corrected age
Receptive language development
The long form version of the Communicative Development Inventories
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 7 months of infant's corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jan 2017
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Helsinki, Tampere University, University of Turku, University of Tartu
- Responsible party
- Principal investigator, Liisa Lehtonen, Turku University Hospital
- Investigators
- Liisa Lehtonen, MD, Principal investigator, University of TurkuSuvi Stolt, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826978
- Sponsor's protocol ID
- T352/2017
- Acronym
- APPLE
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40636560
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Environment by Parents of Preterm Infant; Language Development and Eye-movements
- ClinicalTrials.gov ID
- NCT04826978
- Acronym / sponsor ID
- APPLE / T352/2017
- Conditions
- Infant Development, Preterm Birth, Language Development
- Keywords
- Preterm infant, Neonatal intensive care, Auditory environment, Parent-infant closeness, Social development, Cognitive development, Eye tracker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Helsinki, Tampere University, University of Turku, University of Tartu
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study population: 63 infants from Turku University Hospital and 53 infants from Tallinn Children's Hospital were recruited in 1/2017-12/2020. Inclusion criteria: Born before 32+0 week of gestation without life-threatening diseases or congenital anomalies or syndromes.
Infant auditory environment was recorded for 16 hours at 32+0 to 33+6 weeks of postmenstrual age. In addition, Parental Closeness Diary was recorded for 14 days to measure the parents' presence and parent-infant closeness to get an estimate of language environment of the child during a 14-day period at around 32-34 weeks of gestation. Edinburgh Postnatal Depression Scale was collected during the recording day from both parents to identify parents' risk for perinatal depression. During the day of recording, the research nurse reported the time when a nurse was in the patient room. The auditory environment will be analyzed quantitatively and qualitatively.
Outcomes: Infant face preference for familiar and unfamiliar faces. At the corrected age of 7 months (± 7 days), an eye-tracking based test battery will be used to assess infants' attention to familiar and unfamiliar faces. During the eye-tracking testing, the infants will sit on their parents' lap at ~60 cm distance from a stimulus monitor. Infants' eye movements will be measured by using a screen-based eye-tracker and a video camera.
The test will consist of a task assessing infants' attention to faces expressing neutral, happy and fearful emotion, posed by the infant's own parents and an unfamiliar (female) adult. In this task, the first stimulus (a non-face pattern or a face) is presented at the participant's point of fixation in the center of the computer display, and the second stimulus (a high-contrast distractor) 1 second later ~13-15° to the left or right of the center. Gaze disengagement times from the central to the lateral stimulus will be extracted from the eye tracking data (or from video data, if valid eye tracking data are missing). Disengagement times from trials conforming to the following a priori inclusion criteria will be used in the analyses: i) a sufficient length of fixation on the central stimulus (i.e.,70 % of the time) during the analysis period, which start at the onset of the trial and ends at the onset of gaze disengagement or at maximum time out value (1000 ms post-target), ii) sufficient number of valid samples in the gaze data (i.e., no gaps longer than 200 ms), and, iii) valid information about the eye movement from the central to the lateral stimulus (i.e., the eye movement did not occur during a period of missing gaze data) will be retained for analysis. The duration of attention dwell time on the first stimulus (face or non-face pattern) will be determined for the period starting 150 ms from the onset of the lateral stimulus and ending 1000 ms after the lateral stimulus onset. The duration will then be converted to a normalized dwell time index score by using the formula described in Leppänen et al. (2015). The shortest acceptable saccadic eye movement latency (150 ms) results in a dwell time score of 0, and the longest possible latency (or a lack of saccade, which is equal to the last measured time point of the first stimulus at 1000 ms) in a dwell time index score of 1. The dwell time indices will be calculated separately for each trial and averaged for non-face patterns (i.e., low-salience stimulus), for faces by familiarity (across emotion categories), and for faces by emotion category (across familiarity and separately by familiarity). The primary outcome of the analysis will be the mean dwell times for familiar and unfamiliar faces, adjusted for the mean dwell time for respective non-face patterns. All infants with >2 valid trials per condition will be retained in the final statistical analyses.
Parents' attention and physiological responses to infant faces. Parents attentional and physiological (i.e., pupil dilation) to non-face patterns and faces of their own infant(s) and unknown infants will be assessed at infant age 7 months. Parents will be asked to provide pictures of their own infant(s) prior to each laboratory visit. Pictures displaying positive/content and distressed emotions will be asked.
Picture from an existing dataset will be used as unknown infant pictures. Non-faced patterns will be created by phase-scrambling the pictures so that they retain the low-level characteristics of the original faces, but are not identifiable as faces.
To assess attention, the adults will be asked to follow (by looking) a geometric shape (a checkerboard pattern, measuring 2x2 degrees) as it shifts location from the center of the screen (500-msec) to the left or right side of the screen (~13 degrees from the center). After the participant has shifted gaze from the center to the side (as determined by the eye tracker), the pattern will be replaced by a picture of a non-face pattern or a face for 300-msec. The side of the non-face pattern and face (A= non-face left, face right or B= face left, non-face right) will be alternated between blocks of 20 trials following an ABBA-BAAB design. Using this approach, estimates of saccadic reaction times (SRTs) to the location of own infant face(s) vs. non-faces and two unknown infant faces vs non-face patterns. Because saccadic reaction times will always be initiated by the shifting location of the shape (a checkerboard pattern), any difference in mean SRT must reflect an endogenous or high-level bias towards one of the stimuli (e.g. own infant face), instead of exogenous stimulus properties. To extract attention indicators from the adult data, the latency of gaze shifts between the center of the screen and lateral stimulus positions (following shifts in stimulus position) will be analyzed by using the same procedures as those used for analyzing infant attentional data. To assess parents' sympathetic activation to infant cues, we will follow the procedures of our previous study (Yrttiaho et al., 2017). The adult will see a series of trials consisting of a short 1000-ms pre-stimulus interval with the non-face pattern and a 4000-ms face stimulus (own or unknown infant). Pupil size will be measured from both eyes during the pre-stimulus interval (with random visual pattern that has the same low-level stimulus characteristics as paired face stimulus) and the presentation of the face stimuli. By matching the low-level characteristics of the two consecutive stimuli, the present approach minimizes the possibility that the recorded pupil dilation responses are driven by changes in stimulus luminance. Latencies for each stimulus category will be extracted and used as a primary dependent variable in subsequent statistical analyses. Physiological data from adults (pupil diameter) will be preprocessed using the steps described in our previous study (Yrttiaho et al., 2017), and pupil diameter in two time windows (based on prior studies, these windows will be 300-1200 and 3000-4000 ms after face onset, respectively) will be averaged to extract of pupil constriction and dilation, respectively. The dilation phase will be used as the primary index of sympathetic arousal to infant distress cues.
Information about the child's developing abilities of early language (receptive and expressive language development) will be assessed by MacArthur-Bates Communicative Development Inventory (MCDI) at 12 and 24 months of corrected age.
At two years of corrected age the language skills of the children were measured using the Reynell Development Language Scales III and MacArthur Communicative Development Inventories (the Words and Sentences form). In addition, children's cognitive development was measured using the Bayley Scales of Infant Development III.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 1 week to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Born before 32+0 week of gestation
Key exclusion criteria (1 listed)
- Life-threatening diseases, congenital anomalies or syndromes or chromosomal abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory environmentAuditory environment | Behavioural | – |
Primary outcome
Face recognition by the infant
Time frame: 7 months of corrected age
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.
Expressive language development
Time frame: 24 months of corrected age
Reynell Developmental Language Scales III
Receptive language development
Time frame: 12 to 24 months of corrected age
The long form version of the Communicative Development Inventories
Bayley Scales of Infant Development-III, cognitive scale
Time frame: 24 months of corrected age
A higher score indicates better cognitive development, no set minimum or maximum values, test norm population average is 100.
Physiological parents' saccadic reaction time
Time frame: At 7 months of infant's corrected age
Attention will be assessed as the mean saccadic reaction time in milliseconds to the location of own-child face.
Physiological pupil responses to infant faces
Time frame: At 7 months of infant's corrected age
Pupil dilation will be assessed as pupil diameter in millimetres to face stimuli.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Derived from this study: PubMed 40636560Aija 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liisa Lehtonen, MD principal investigator
University of Turku
Suvi Stolt, PhD principal investigator
University of Helsinki
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development and Preterm Birth, run by Turku University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Face recognition by the infant (time frame: 7 months of corrected age). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04826978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.