Premature Infant Clinical Trial
— PAPSOfficial title:
The Efficiency of Using Supportive Postures and Holding Techniques in Order to Minimize Premature Infant Pain During Naso-gastric Tube Insertion, in the Presence or Absence of the Mother.
Verified date | December 2022 |
Source | Centre Hospitalier Régional Metz-Thionville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out. It has been shown that the environment in which the procedure is performed (e.g with skin to skin contact and specific positioning), reduces the discomfort felt by the newborn. However, this has not yet been proven with regards to naso-gastric tube insertion.
Status | Suspended |
Enrollment | 120 |
Est. completion date | July 1, 2027 |
Est. primary completion date | November 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Preterm baby born between the 32th and the 35th weeks of amenorrhea plus 6 days - Prescription of enteral nutrition via naso-gastric tube - Naso-gastric tube in-situ - Informed consent of both parents Exclusion Criteria: For the newborn - Under respiratory assistance - With nasal or buccal malformation - With abnormal heart rhythm or congenital heart disease - With hemodynamic instability - Transfer to type 3 neonatal unit - With a DAN score > 0 before treatment - With an umbilical venous catheter in-situ - Fed with thickened milk - Prescription of analgesic medications For the parents - Minor - Under legal protection - Difficulties which do not permit the mother to carry out skin-to skin contact or holding support |
Country | Name | City | State |
---|---|---|---|
France | CHR Metz Thionville | Metz |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional Metz-Thionville |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain during insertion of the probe | Evaluation of the newborn's pain during insertion of the naso-gastric tube using the Premature Infant Pain Profile (PIPP) scale. The PIPP consists of 3 behavioral (facial actions: brow bulge, eye squeeze, and nasolabial furrow) and 2 physiological (heart rate and oxygen saturation) indicators, and 2 contextual [gestational age (GA) and behavioral state] variables that modify pain. In the same time, the heart rate and oxygen saturation of the newborns were measured using a pulse oximeter. | Day 1 | |
Secondary | Evaluation of pain using the DAN scale | This scale scores pain from 0 to 10, where 0 is no pain and 10 is maximum pain; it evaluates three items: facial expressions, limb movements and vocal expression. | Day 1 | |
Secondary | Maternal satisfaction | Mother's satisfaction with regards to her involvement in the procedure. The questions are about her sense of usefulness during the probe, her knowledge of child's reaction and her desire to repeat the experience. | Day 1 | |
Secondary | Professional's satisfaction | Health carers satisfaction during the procedure. The questions are about his appreciation of the effective management of the pain, the ease of installation, the benefits of the mother's presence and his desire to repeat the experience. | Day 1 | |
Secondary | Duration of the Naso -gastric tube in situ | Lifetime of the probe after insertion | Day 7 | |
Secondary | Procedure time | Time taken to insert the naso-gatric tube | Day 1 |
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