Skip to content

CLEfts and FEeding Difficulties (CLEFED-1): The effect and timing of surgical closure in children with cleft palate.

CLEfts and FEeding Difficulties (CLEFED-1): The effect and timing of surgical closure in children with cleft palate.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27970
Enrollment
80
Registered
2012-02-06
Start date
2012-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Cleft, cleft palate, clefts, feeding difficulties, timing surgical closure, schisis, palatoschisis, voedingsproblemen

Interventions

One group will undergo surgical closure between the age of 6-8 months and the other group between the age of 10-12 months. All patients will undergo this intervention following the standard, current p

Sponsors

University Medical Center Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Childeren born with a cleft lip and palate or cleft palate that visit the cleft team; 2. Inclusion at the age of 5 months; 3. Adequate understanding of the Dutch language by the parents; 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Children that were adopted; 2. Children that are previous seen by another cleft-team (another hospital); 3. No informed consent.

Design outcomes

Primary

MeasureTime frame
1. Feeding techniques and skills, defined by scores from Montreal Children’s Hospital Feeding scale (MCH), Nijmeegse Observatielijst Lepelvoeding (NOL) and an observation lists focussed on children with clefts; 2. Weight gain (growth), defined by the difference in measurements (standard deviation) marked on a standardized growth-curve.

Secondary

MeasureTime frame
1. NS feeding (and duration); 2. Extent of the cleft palate; 3. Associated malformations; 4. Upper respiratory infections / pneumonia; 5. Medication (child); 6. Placement of grommets (middle ear tubes); 7. Complications/adverse effects.

Contacts

Public ContactI.A.C. Vries, de

Division of Pediatric Plastic Surgery Wilhelmina Children's Hospital University Medical Center Utrecht P.O.Box 85090 KE.04.140.0

i.a.c.devries-5@umcutrecht.nl+31 (0)88 7554004

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)