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Multimodal Parameter Extraction and Feature Analysis of Lactating Women

Multimodal Parameter Extraction and Feature Analysis of Lactating Women

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114998
Enrollment
Unknown
Registered
2025-12-19
Start date
2025-12-20
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactation disorder

Interventions

Normal group:None

Sponsors

School of Life Science and Technology, Northwestern Polytechnical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Normal Group Participants: (1) Age: 18<=age<=40 years; (2) BMI: 18.5 kg/m^2 <= BMI <= 30.0 kg/m^2; (3) Primiparous women with a singleton vaginal birth or cesarean section; (4) Time window: 3 weeks to 1 year postpartum; (5) Normal lactation, exclusively breastfeeding without the need for supplementary formula; (6) Able to cooperate with data collection before, during, and after lactation; (7) No history of any psychological problems; (8) Able to understand the trial process and provide informed consent independently. 2. Experimental Group Participants: (1) Age: 18<=age<=40 years; (2) BMI: 18.5 kg/m^2 <= BMI <= 30.0 kg/m^2; (3) Primiparous women with a singleton vaginal birth or cesarean section; (4) Time window: 3 days to 1 year postpartum; (5) Able to cooperate with data collection before, during, and after lactation; (6) Able to understand the trial process and provide informed consent independently.

Exclusion criteria

Exclusion criteria: 1. Subjects in the normal group: (1) Multiple pregnancies; (2) History of breast surgery such as breast augmentation or tumor removal; (3) Currently suffering from severe mastitis or breast abscess; (4) Suffering from pituitary tumors, uncontrolled thyroid dysfunction, or other related diseases; (5) History of clearly diagnosed neurological or psychiatric disorders; (6) Scalp infections or damage (affecting EEG-fNIRS electrode placement); (7) Damage or eczema on breast skin (affecting EIM electrode or ultrasound probe placement). 2. Subjects in the experimental group: (1) Multiple pregnancies; (2) History of breast surgery such as breast augmentation or tumor removal; (3) Currently suffering from severe mastitis or breast abscess; (4) Suffering from pituitary tumors, uncontrolled thyroid dysfunction, or other related diseases; (5) History of clearly diagnosed neurological or psychiatric disorders; (6) Scalp infections or damage (affecting EEG-fNIRS electrode placement); (7) Damage or eczema on breast skin (affecting EIM electrode or ultrasound probe placement).

Design outcomes

Primary

MeasureTime frame
Neurovascular coupling metrics under simultaneous EEG-fNIRS multimodal acquisition;Neurovascular coupling metrics under simultaneous EEG-fNIRS multimodal acquisition;Milk volume, breastfeeding/pumping, and real-time maternal physiological data;

Secondary

MeasureTime frame
Time-frequency features of EEG during lactation;Hemodynamic characteristics of fNIRS signals during lactation;Neurovascular coupling strength and network topological features based on EEG-fNIRS fusion;

Countries

China

Contacts

Public ContactLi Le

School of Life Science and Technology, Northwestern Polytechnical University

lile5@nwpu.edu.cn+86 135 6041 5367

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026