Evaluation of an individual, family-integrated, development-supporting care program for preterm born infants in the NICU

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017781

Enrollment

300

Registered

2019-09-17

Start date

2019-09-05

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

P07.2 P07.3

Interventions

Group 1: Preterm infants Neo3 (treatment according to actual standard of care) and their parents Group 2: Preterm infants Neo4 (treatment according to concept of individual and family integrating care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Maximum age: 31+6 weeks of gestation (at the time of study inclusion) Others: - Prematurity (< 32+0/7 weeks of gestation) - Admission of the infant within the first week of life - communication with parents in German/English (German is mandatory for participation in the parent survey) Additional inclusion criteria for arm 1 - Neo4: - Care of the preterm born infant for at least 3 weeks on the NICU Neo4 - Presence of parents of at least 6 hours a day and at least 50% of nights (average during the entire stay at Neo 4)

Exclusion criteria

Exclusion criteria: - Preterm born infants who are known prior to birth or within the first few days of life to require palliative treatment. - Congenital malformations - Indication for primary surgical therapy - language barriers or non-readability of parents - Indication of ECMO

Design outcomes

Primary

Measure	Time frame
Rate of completely breastfed infants on discharge (infants) Prevalence / intensity of subjective distress of the parents 3-4 months after discharge (parents)	—

Secondary

Measure	Time frame
For the infant - Length of stay in hospital - Frequency of NEC/FIP, IVH/PVL, ROP, BPD - Length of ZVK/parenteral nutrition - weight development - days of ventilation and need of oxygen - parameter for long-term outcome 3-4 months after discharge (body weight, length, head circumference, sleep, nutrition, behavior) for the parents: - prevalence / intensity of anxiety / stress - bonding and parental competency - Need of follow-up care - General satisfaction with care	—

Measure

Time frame

For the infant - Length of stay in hospital - Frequency of NEC/FIP, IVH/PVL, ROP, BPD - Length of ZVK/parenteral nutrition - weight development - days of ventilation and need of oxygen - parameter for long-term outcome 3-4 months after discharge (body weight, length, head circumference, sleep, nutrition, behavior) for the parents: - prevalence / intensity of anxiety / stress - bonding and parental competency - Need of follow-up care - General satisfaction with care

—

Countries

Germany

Contacts

Public ContactAnna-Lisa Sorg

Klinik für Kinder- und Jugendmedizin Abteilung Neonatologie

Anna-lisa.sorg@med.uni-tuebingen.de07071-2962371

Outcome results

None listed

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