Clinical trial NCT03939169: The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
Official 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.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Premature Infant
Keywords: pain
naso-gastric tube
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Our clinical study (carried out in the Neonatology Unit of Mercy Regional Hospital) has shown that when positioning and other non drug related analgesic techniques are used, newborns undergoing naso-gastric tube insertion feel less pain.

Several different techniques were used, such as skin-to-skin contact with the mother and/or positioning the infant using appropriate equipment, or the "four hands" technique carried out by two health care professionals.

Neonatal unit staff were able to choose the method used depending on whether the mother was present at the time of the procedure.

In cases where the mother was absent, the "four hands technique" was favored, but in the presence of the mother skin-to-skin contact was preferable.

Eligibility criteria: 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

Primary outcomes:
measure: Pain during insertion of the probe
timeFrame: Day 1
Secondary outcomes:
measure: Evaluation of pain using the DAN scale
timeFrame: Day 1
measure: Maternal satisfaction
timeFrame: Day 1
measure: Professional's satisfaction
timeFrame: Day 1
measure: Duration of the Naso -gastric tube in situ
timeFrame: Day 7
measure: Procedure time
timeFrame: Day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
Study officials:
References: