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

Premature Infant Clinical Trial

— PAPS  

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.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03939169
• Other study ID #: 2016-07-CHRMT
• Status: Suspended
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: July 1, 2027

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Premature Birth
• Premature Infant

Intervention

Other:
• Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment

Locations

Country	Name	City	State
France	CHR Metz Thionville	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

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