STRess and Outcomes in Neonatal Intensive Care Unit Graduates (STRONG)

STRess and Outcomes in NICU Graduates (STRONG): Studying the effects of stress exposure on preterm infants’ epigenetic profile and early childhood outcomes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN62164166

Enrollment

108

Registered

2019-02-25

Start date

2019-09-01

Completion date

Unknown

Last updated

2025-05-05

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

Conditions

Stress exposure during Neonatal Intensive Care Treatment Pregnancy and Childbirth

Interventions

Participants in this observational cohort study will be treated according to usual care, we will collect data from medical files (stress measures) and ask nurses to rate stress. Children will be video

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gestational age below 30 weeks and/or birth weight below 1000 grams 2. Admittance to Neonatal Intensive Care Unit of the University Medical Center Groningen 3. Written informed consent from both parents

Exclusion criteria

Exclusion criteria: 1. Inability of parents to speak/understand Dutch

Design outcomes

Primary

Measure	Time frame
DNA methylation pattern of our primary stress-related candidate gene (NR3C1 gene), measured in gastro-intestinal cells, cord blood and placenta using pyrosequencing, in relation to stress exposure measured at birth, before discharge, 3, 6, 9 and 12 months of age.	—

Secondary

Measure	Time frame
1. DNA methylation patterns of our other stress-related candidate genes measured in gastro-intestinal cells, cord blood and placenta using pyrosequencing, in relation to stress exposure 2. Stress levels of the child, measured by the neonatal infant stressor scale each day during stay in the neonatal intensive care unit, 3. Stress levels of the child according to the neonatal nurses, using a Likert scale each shift and using the COMFORT neo scores each shift. 4. Short-term neurological outcome, as assessed by General Movements Assessment at two weeks and three months of age 5. Long-term neurological outcome, as assessed by the Ages and Stages Questionnaire at 12 months of age 6. Infant quality of life, as assessed by the Infant Quality of Life Instrument at 3, 6, 9 and 12 months of age	—

Measure

Time frame

1. DNA methylation patterns of our other stress-related candidate genes measured in gastro-intestinal cells, cord blood and placenta using pyrosequencing, in relation to stress exposure 2. Stress levels of the child, measured by the neonatal infant stressor scale each day during stay in the neonatal intensive care unit, 3. Stress levels of the child according to the neonatal nurses, using a Likert scale each shift and using the COMFORT neo scores each shift. 4. Short-term neurological outcome, as assessed by General Movements Assessment at two weeks and three months of age 5. Long-term neurological outcome, as assessed by the Ages and Stages Questionnaire at 12 months of age 6. Infant quality of life, as assessed by the Infant Quality of Life Instrument at 3, 6, 9 and 12 months of age

—

Countries

Netherlands

Outcome results

None listed

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