Alternation of infants for the prevention and correction of postural skull deformities - Studies concerning the safety of use of a side rail storage

Alternation of infants for the prevention and correction of postural skull deformities - Studies concerning the safety of use of a side rail storage - VARILAG

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006734

Enrollment

Registered

2014-09-10

Start date

2014-11-03

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

M95.2

Interventions

Group 1: 1. only storage of the infant for 4 hours without side-rail storage, then change to storage for 4 hours with side-rail storage 2. monitoring beginning with the Quiet are of the infant to slee

Eligibility

Sex/Gender

All

Age

No minimum to 7 Months

Inclusion criteria

Inclusion criteria: 1. premature babies / infants aged betw. 36th week and the end of the seventh month of life 2. written parental consent

Exclusion criteria

Exclusion criteria: 1. acutely ill children 2. after vaccination at a distance less than one week 3. malformation syndromes 4. children with constantly increased oxygen demand 5. children with hydrocephalus and ventriculoperitonealer derivation

Design outcomes

Primary

Measure	Time frame
Mean of the average oxygen saturation	—

Secondary

Measure	Time frame
1.% share of sleep at the monitoring time 2.% proportion of quiet sleep 3. RDI (Respiratory Disturbance Index) 4. relevant bradycardia (heart rate below 80 / min.) 5. related apneas (about 15 seconds) 6. desaturation below 90% 7. frequency of position changes in the prone position monitoring time per	—

Countries

Germany

Contacts

Public ContactUta Beyer

Universitätskinderklinik MagdeburgSchlaflabor

uta.beyer@med.ovgu.de0391-67-24013

Outcome results

None listed

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