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The use of Breast Milk compared to Glucose to reduce Pain during Collection of Examination in preterm infants

Analgesic effect of Maternal Milk versus 25% Glucose during the collection of Arterial Blood Gases in preterm newborns: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4sspn6
Enrollment
Unknown
Registered
2017-08-15
Start date
2017-01-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn. Pain. Neonatal Intensive Care. Respiratory Diseases.

Interventions

Experimental group: The intervention used was breast milk. 35 newborns will receive 0.5 ml of breast milk in the sublingual region during collection of arterial blood gases. The study is being perform
Other
E03.091
E01.370.600.550.324

Sponsors

Maternidade Escola Assis Chateaubriand-MEAC
Lead Sponsor
Maternidade Escola Assis Chateaubriand-MEAC
Collaborator
Universidade Estadual do Ceará-UECE
Collaborator

Eligibility

Age
No minimum to 36 Weeks

Inclusion criteria

Inclusion criteria: All clinically stable preterm NBs were considered eligible; Regardless of gestational age (GI); Weight greater than or equal to 500 g and with a minimum; 12 hours of life and hospitalized in high risk beds in Neonatal Intensive Care Units; Making use of some form of oxygen therapy; Since most of these patients have respiratory disorders and require oxygen to improve the clinical picture. All the newborns submitted to the procedure of collection of arterial blood gases by clinical indication and medical prescription were also included in the study.

Exclusion criteria

Exclusion criteria: Newborns less than 12 hours old were excluded; Due to hemodynamic and respiratory instability. As a consequence, neonates with clinical instability were also excluded; The malformed ones; Children of chemical dependents; Women seropositive for the Human Immunodeficiency Virus (HIV); Neonates who have undergone recent surgical procedures; Those who have been using sedation or analgesia (fentanyl or dormonid); Those with neurological manifestations; Such as convulsions and the children of mothers with psychiatric problems; Due to the use of some medications contraindicated for breastfeeding.

Design outcomes

Primary

MeasureTime frame
Presentation of the expected outcome: Relief of pain during the painful procedure of arterial blood gas analysis, that is, pain relief will be noticed 2 minutes after the application of the intervention, a time that coincides with the moment immediately after the painful procedure of arterial blood gas analysis. Presentation of the method used to verify the expected outcome: using fresh milked oral milk (Experimental group) or 25% glucose (Control group) in the sublingual region of the newborn at the moment before the collection of blood gases. Presentation of the parameters: pain relief will be measured by the evaluation of changes in the physiological parameters of heart rate and oxygen saturation in the three moments of the study. The alterations of these parameters will be compared in the three moments of the study to evaluate the pain relief during the arterial blood gas analysis.;Presentation of expected outcome: Pain relief of preterm newborns was not observed in either group (experimental group and control group) after the intervention. Presentation of the method used to verify the expected outcome: using fresh milked oral milk (Experimental group) or 25% glucose (Control group) in the sublingual region of the newborn at the moment before the collection of blood gases. There was a change in heart rate at the time immediately after the collection of arterial blood gases (p> 0.05) in the two groups (experimental group and control group), when compared to zero moment and before the collection of the exam.

Secondary

MeasureTime frame
Presentation of the expected outcome: During the collection of arterial blood gases, changes in the physiological parameters of heart rate and oxygen saturation in the two intervention groups will be visualized and a comparison of the changes of these parameters between the experimental group and the control group will be performed in the three moments of the intervention. study. Presentation of the method used to verify the expected outcome: To verify the changes in the physiological parameters of heart rate and oxygen saturation in the two groups, a pulse oximeter will be used and the measurement of the parameters will be performed through a Vollo brand stopwatch for one minute after time zero, one minute after the moment immediately before and one minute at the moment immediately after collection of arterial blood gas. Presentation of the parameters: changes in the physiological parameters of heart rate and oxygen saturation will be visualized in the three moments of the study by means of the pulse oximeter.;Presentation of effectively observed outcomes: Both breast milk and glucose had a maximal and minimal heart rate increase at the time immediately after collection of arterial blood gas (p 0.05) for the physiological parameters of heart rate and oxygen saturation during the procedure arterial blood gas analysis.

Countries

Brazil

Contacts

Public ContactAndréa Barbosa

Universidade Estadual do Ceará-UECE

andrea_lopes_barbosa@hotmail.com55 (85) 31019890

Outcome results

None listed

Source: REBEC (via WHO ICTRP)