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

Phase 3

Recruiting

• Conditions: P07.2; P07.3; Extreme immaturity; Other preterm infants

• Registration Number: DRKS00017781
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of completely breastfed infants on discharge (infants)<br>Prevalence / intensity of subjective distress of the parents 3-4 months after discharge (parents)

Secondary Outcome Measures

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