Baby Breathing Monitoring @Home

NCT05175560 | Completed

• 2 other identifiers: ICBE-S-000608NL79600.100.21
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To give reassurance to parents, Philips would like to add algorithms to the NightOwl baby monitor to be able to measure baby behavior and physiology. In this study, the investigators aim to investigate the applicability of in-house breathing algorithms, and to develop algorithms, for babies sleeping in a home setting. The data collection will be divided in several sub-studies, either e.g. matching different development steps in the development of the algorithm or focusing on a specific baby population (e.g. specific age range). In general, babies will be monitored (audio, video, activity) for 24 -48 hours under their habitual sleeping conditions. Step 1: 3 full data sets will be recorded of babies in bed aged 3 weeks to about 3-4 months, who are not able to turn over yet. Data will be analyzed and study set-up will be checked. Parents will be asked to keep a baby sleep diary and a questionnaire will be filled in at the start, with questions regarding the sleep behavior of their child. At the end, parents will be asked to fill in a questionnaire with sleep-related and feedback questions. In step 2, 5 full data sets will be collected following the same procedure as step 1. In step 3 12 full data sets will be collected following the same procedure as step 1. After each step, the study setup including the algorithms, will be reviewed based on the obtained data. All modifications to this protocol will be submitted as amendments. After step 1 and 2, the Mother and Child Care Business unit of Philips and other relevant stakeholders will be updated on the progress and findings by means of a (short) meeting and PowerPoint slides. After step 3, a report will be written. The PowerPoint slides shared after Step 1 and 2 will be incorporated in this report.

Conditions

Healty Babies; 3 Weeks - 3 Months Old

Keywords

Infants; physiology; behavior; respiration; sleep; unobtrusive monitoring; home setting

Outcome Measures

Primary Outcomes (1)

• Can we measure baby behavior and physiology by camera and / or wearable?

  through study completion, up to 1 year

Secondary Outcomes (5)

• Can we measure breathing at all by camera when the baby is in bed?

  up to 3 months

• Can we measure when the baby is in and out of bed?

  up to 3 months

• Can we derive sleep stages from the data?

  up to 3 months

• Can we detect and / or interpret baby crying?

  up to 3 months

• Can we distinguish the baby (audio & movement) from other people near the bed (i.e. parents and/or siblings)?

  up to 3 months

Eligibility Criteria

• Age: 3 Weeks - 4 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

healthy infants and their parents

You may qualify if:

• Parents or caregivers :

You may not qualify if:

• Have a baby who sleeps in its own bed (i.e. different sleeping surface than parents; same room is allowed);
• Live in the Netherlands;.
• Are able to speak and read Dutch or English.
• Parents or caregivers
• with a baby who can already roll over (belly to back and back to belly);
• with a baby who is under supervision of an HCP because of health, feeding or developmental problems ;
• are unwilling or unable to provide informed consent on behalf of themselves, their baby and siblings;
• are unwilling or unable to comply with the study requirements;
• do not give permission to use their, or that of potential siblings, audio-video image data recorded during the study as described in the information letter and privacy notice;
• are not able to fill in the questionnaires and baby sleep diary.

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization: lead

Study Sites (1)

Philips Research

Eindhoven, North Brabant, 5656 AE, Netherlands

Location

Related Publications (4)

• Yue Sun, Wenjing Wang, Xi Long, Mohammed Meftah, Tao Tan, Caifeng Shan, Ronald M. Aarts, Peter H.N. de Widt; Respiration Monitoring for Premature Neonates in NICU; Appl. Sci. 2019, 9(23), 5246; https://doi.org/10.3390/app9235246

  BACKGROUND

• Lorato I, Stuijk S, Meftah M, Kommers D, Andriessen P, van Pul C, de Haan G. Towards Continuous Camera-Based Respiration Monitoring in Infants. Sensors (Basel). 2021 Mar 24;21(7):2268. doi: 10.3390/s21072268.

  PMID: 33804913 BACKGROUND

• Khan AU, Mikut R, Reischl M. A Benchmark Data Set to Evaluate the Illumination Robustness of Image Processing Algorithms for Object Segmentation and Classification. PLoS One. 2015 Jul 20;10(7):e0131098. doi: 10.1371/journal.pone.0131098. eCollection 2015.

  PMID: 26191792 BACKGROUND

• Sadeh A. A brief screening questionnaire for infant sleep problems: validation and findings for an Internet sample. Pediatrics. 2004 Jun;113(6):e570-7. doi: 10.1542/peds.113.6.e570.

  PMID: 15173539 BACKGROUND

MeSH Terms

Conditions

Behavior; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Renee Otte, dr

  Philips Electronics Nederland B.V. acting through Philips CTO organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 4, 2022
• Study Start: February 7, 2022
• Primary Completion: September 6, 2022
• Study Completion: October 10, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: the data will be shared after the data have been annotated and annotated data has been removed. Data will be available for maximum 20 years.

Locations

NL (1)