6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks

Cerebral palsy assessed using the Gross Motor Function Classification System (GMFCS), a five-level classification based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.

Severe/moderate cerebral palsy (GMFCS≥2). Mild cerebral palsy (GMFCS-1).

Measured using the Developmental Coordination Disorder Questionnaire - European French (DCDQ-FE), a brief parent questionnaire (15 items) designed to screen for gross and fine motor skills and coordination disorders in children, aged 5 to 15 years.

Total score=15-56: indication of a risk of DCD or suspected of a risk of DCD. Total score=57-75: probably no DCD.

Language assessed using the verbal communication subscale (4 items) of the 5-15R scale, covering comprehension, expressive language skills and verbal communication, with an extra question on the impact of language and communication difficulties on daily activities.

Mean (SD). Reference to cut-off scores in relation to the 90 and 98 percentiles (%).

Behavior assessed using the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire (25 items), designed to screen for symptoms of hyperactivity inattention, emotional, conduct, and peer problems among 2-17 year olds.

Mean (SD). Abnormal: >90th percentile. Mildly abnormal: 80-90 percentile.

Executive functions measured using the Childhood Executive Functioning Inventory (CHEXI), a rating instrument (24 items) for parents that was developed for measuring executive functioning in children age 4-12. It includes four different subscales tapping working memory, planning, regulation and inhibition, combined into two global scales: working memory (working memory and planning subscales) and inhibition (inhibition and regulation subscales).

Normative data are not yet available. Abnormality will be defined considering a cut-off or deviation compared to the mean score, depending on the literature.

Whether the child is alive or not at years of age.

Moderate-to-severe impairment (severe/moderate cerebral palsy, and/or abnormal SDQ score, and/or NEMI-3 ≥2 SD below the mean, and/or blindness, and/or deafness), mild impairment (mildly abnormal scores or mild impairment) vs no neurodevelopmental impairment.

Survival without any neurodevelopmental impairment (as defined in the primary endpoint, and then including also cognitive impairment).

Survival without moderate-to-severe neurodevelopmental impairment (i.e. severe/moderate cerebral palsy, and/or abnormal SDQ score, and/or NEMI-3 ≥2 SD below the mean, and/or blindness, and/or deafness).

Height compulsory examination in the sixth year, reported in the health book.

Weight. Compulsory examination in the sixth year, reported in the health book

Arterial pressure. Compulsory examination in the sixth year, reported in the health book.

chronic diseases, compulsory examination in the sixth year, reported in the health book

oral health. Compulsory examination in the sixth year, reported in the health book

Visual acuity, any vision problem mentioned. Compulsory examination in the sixth year, reported in the health book.

Hearing test. Compulsory examination in the sixth year, reported in the health book.

Data reported in the health book during the compulsory examination in the sixth year.

Language test. Compulsory examination in the sixth year, reported in the health book.

Data reported in the health book during the compulsory examination in the sixth year.

NEMI-3: an intelligence test administered by a psychologist measuring a fluid and crystallised intelligence. The test consists of 117 spoken and visual questions, for a total administration time of 45 min. Results are expressed in the form of standard indices (mean 100, standard deviation 15) that facilitate comparisons with the results obtained on other intelligence scales.

Results will be classified as normal, mild delay (between 1 and <2 standard deviation [SD] below the mean) or severe delay (≥2 SD).

Acceptability E-Scale (adapted - 3 items), participation and completion rates, technical difficulties.

Self-reported. Perceived health and development of the child, parental concerns about health and development, and professional diagnoses of health conditions (e.g., asthma, respiratory problems, etc.).

PedsQL Short Form - 15 items. All items will be added up and linearly transformed on a scale between 0 and 100, a higher score indicating a better HRQoL. Physical and psychosocial functioning will be further assessed using the corresponding subscales. Poor HRQoL, physical or psychosocial functioning will be defined using thresholds compatible with a severe health condition.

Ad-hoc questions

Minimum European Health Module - 1 item

PHQ-4 (anxiety and depression) - 4 items

WHO-5 Well-Being Index - 5 items

WHOQOL bref FR - 1 item