The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP) (PAPS)

Centre Hospitalier Régional Metz-Thionville

Status: Terminated

Conditions: Premature Infant

Treatments: Other: Installation of a naso-gastric feeding tube

Study type: Interventional

Funder types: Other

Identifiers

NCT03939169

2016-07-CHRMT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 4 patient groups

Skin-to-skin support

Other group

Description:

The newborn is dressed in one layer of clothing with a hat, he is placed in the ventral position directly on the mother's chest, covered with a warm blanket and held in place with a band during the insertion of the naso-gastric feeding tube.

Treatment:

Other: Installation of a naso-gastric feeding tube

Holding

Other group

Description:

The newborn is held in his mother's arms during insertion of the naso-gastric feeding tube.

Treatment:

Other: Installation of a naso-gastric feeding tube

Four hands care

Other group

Description:

Carried out by two professionals: one health-care professional supports the child and helps stabilize the newborn whilst the other professional inserts the naso-gastric feeding tube.

Treatment:

Other: Installation of a naso-gastric feeding tube

Containing support with equipment

Other group

Description:

Carried out by one healthcare Professional, who places the newborn in such a manner that he will be held in the optimum position (using a soft sheet) during the insertion of the naso-gastric feeding tube.

Treatment:

Other: Installation of a naso-gastric feeding tube