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Infant, PrematureNCT05097495

Non-Nutritive Sucking vs Non-Nutritive Sucking Combined With Breast Milk on the Neonatal Comfort

A study testing Only NNS and NNS Combined with Breast Milk in people with Infant, Premature, run by Acibadem University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to determine the effect of the use of non-nutritive sucking vs non-nutritive sucking combined with breast milk on neonatal comfort during diaper change in preterm infants. Read more about this study

Who is it for?
Ages 1 day to 28 days
Conditions the study is for
Infant, Premature
What is being tested?
Only NNS and NNS Combined with Breast Milk
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2021to 23 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The preterm infants whose parents agree to participate in the research and sign the informed consent form;
  • Who have no congenital anomaly;
  • Who have no chronic disease;
  • Who have undergone no surgical procedure;
  • Who have no neurological symptoms;
  • Who have no NEC (necrotizing enterocolitis) diagnosis;
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  • Who are not sedated;
  • Who are not hypoglycemic;
  • Who have been administered no pharmacological analgesic method 4 hours before;
  • Who are born between ≥28 and ≤36+6 gestation weeks, or are in between ≥28 and ≤36+6 gestation weeks during the procedure.

Who cannot join

  • The infants whose parents do not agree to participate in the research and do not sign the informed consent form;
  • Who have a congenital anomaly;
  • Who have a chronic disease;
  • Who had undergone a surgical procedure;
  • Who have neurological symptoms;
  • Who have NEC (necrotizing enterocolitis) diagnosis;
Show all 10Show fewer
  • Who are sedated;
  • Who are hypoglycemic;
  • Who have been administered no pharmacological analgesic method 4 hours prior;
  • Who were between <28 and >36+6 gestation weeks.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Şişli Kolan International Hastanesi

    Istanbul, Şişli, 34360

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of the Use of Non-Nutritive Sucking vs Non-Nutritive Sucking Combined With Breast Milk on the Neonatal Comfort During Diaper Change in Preterm Infants

The aim of the study is to determine the effect of the use of non-nutritive sucking vs non-nutritive sucking combined with breast milk on neonatal comfort during diaper change in preterm infants.

Read the detailed description

Newborns are faced with many painful interventions including tactile stimulation such as diaper change, axillary temperature measurement, intraoral and endotracheal aspiration during the postnatal period in the Neonatal Intensive Care Units (NICU) at the beginning of their lives. Painful interventions negatively affect the physiological parameters, comfort, sleep, growth and hospital stay of newborns. As a result of these interventions, the stress level increases in preterm infants. Increased stress level can cause long-term sequelae, risk of intraventricular hemorrhage, increased oxygen consumption and hypertension. In addition, the increased stress experience may make the infant sensitive to pain and stress in other periods of his life.

This randomized controlled prospective study was planned to be conducted in the NICU of a private hospital with branches in Istanbul until the whole sample group would be reached.

In the NICU, where the study will be conducted, preterm infants will be divided into two groups as control and experimental groups. Non-nutritive sucking (NNS) combined with breast milk will be used during diaper change for newborns in the experimental group, and only NNS will be used in the control group. NNS will be given to both groups 5 minutes before diaper change. The comfort level of the newborns will be measured with the Premature Infant Comfort Scale before the NNS, 5 minutes after the NNS, during the procedure, immediately after the procedure and 5 minutes after the procedure.

Being tested
Only NNS, NNS Combined with Breast Milk
Keywords
Non Nutritive Sucking, Preterm Infant, Comfort
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Only NNSProcedure or surgery

    Before the procedure, the Premature Infant Comfort Scale shall be filled out.

    Procedure steps for the control group:

    • Materials shall be prepared (napkins, non-sterile gloves, pacifier)
    • Hands shall be washed; gloves shall be worn.
    • The infant shall be given a NNS just before the procedure and continue until the 5th minute after the procedure.
    • The diapers shall be changed.
    • Hands shall be washed after the procedure.
    • The Premature Infant Comfort Scale shall be assessed during, shortly after, and 5 minutes after the procedure.

  • NNS Combined with Breast MilkProcedure or surgery

    • Before the procedure, the Premature Infant Comfort Scale shall be filled out.
    • Materials shall be prepared (napkins, non-sterile gloves, pacifier, breast milk, cup)
    • Hands shall be washed; gloves shall be worn.
    • The cylindrical part of a pacifier shall be in touch with breast milk for 5 seconds. The infant shall be given the pacifier, combined with breast milk, just before the procedure and continue until the 5th minute after the procedure.
    • The diapers shall be changed.
    • Hands shall be washed after the procedure.
    • The Premature Infant Comfort Scale shall be assessed during, shortly after, and 5 minutes after the procedure.
Study groups in NCT05097495
Study groupRoleWhat they receive
Control group (Only NNS)ExperimentalNNS will be started 5 minutes before diaper change. The use of NNS will continue during diaper change and up to 5 minutes after the application.
Receives: Procedure: Only NNS
Experimental Group (NNS Combined with Breast Milk)ExperimentalNNS combined with breast milk will be started 5 minutes before diaper change. The use of NNS combined with breast milk will continue during diaper change and up to 5 minutes after the application.
Receives: Procedure: NNS Combined with Breast Milk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Comfort Level

    Infant's comfort level is evaluated with Premature Infant Comfort Scale.Premature Infant Comfort Scale (PICS), which is a multidimensional scale used in evaluating comfort and pain behaviorally and psychologically. The lowest score obtained from the scale is 35, and the highest score is 7. A high score on the scale indicates a low level of comfort.

    Measured: 5 minutes before, immediately before, during, immediately after, and 5 minutes after the procedure.The change in these time intervals will be assessed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2021
  2. Study start1 Nov 2021
  3. Primary completion23 Jun 2022
  4. Study completion23 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05097495
Sponsor's protocol ID
ATADEK-2021/15
Status last verified
Jan 2023
First submitted
11 Oct 2021
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gibbins S, Stevens B. Mechanisms of sucrose and non-nutritive sucking in procedural pain management in infants. Pain Res Manag. 2001 Spring;6(1):21-8. doi: 10.1155/2001/376819.

    PubMed 11854758

  • Lyngstad LT, Tandberg BS, Storm H, Ekeberg BL, Moen A. Does skin-to-skin contact reduce stress during diaper change in preterm infants? Early Hum Dev. 2014 Apr;90(4):169-72. doi: 10.1016/j.earlhumdev.2014.01.011. Epub 2014 Feb 16.

    PubMed 24548816

  • De Bernardo G, Riccitelli M, Sordino D, Giordano M, Piccolo S, Buonocore G, Perrone S. Oral 24% sucrose associated with nonnutritive sucking for pain control in healthy term newborns receiving venipuncture beyond the first week of life. J Pain Res. 2019 Jan 8;12:299-305. doi: 10.2147/JPR.S184504. eCollection 2019.

    PubMed 30662283

  • Naughton KA. The combined use of sucrose and nonnutritive sucking for procedural pain in both term and preterm neonates: an integrative review of the literature. Adv Neonatal Care. 2013 Feb;13(1):9-19; quiz 20-1. doi: 10.1097/ANC.0b013e31827ed9d3.

    PubMed 23360853

  • Wu HP, Yang L, Lan HY, Peng HF, Chang YC, Jeng MJ, Liaw JJ. Effects of Combined Use of Mother's Breast Milk, Heartbeat Sounds, and Non-Nutritive Sucking on Preterm Infants' Behavioral Stress During Venipuncture: A Randomized Controlled Trial. J Nurs Scholarsh. 2020 Sep;52(5):467-475. doi: 10.1111/jnu.12571. Epub 2020 Jun 20.

    PubMed 32564489

Questions about this trial

What is this clinical trial studying?

A study testing Only NNS and NNS Combined with Breast Milk in people with Infant, Premature, run by Acibadem University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Comfort Level (time frame: 5 minutes before, immediately before, during, immediately after, and 5 minutes after the procedure.The change in these time intervals will be assessed.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05097495, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.

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