Hemodynamic Repercussions in Different Therapeutic Positions in Premature Newborn

NCT05145114 | Completed DMC

• 1 other identifier: 3.983.789
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Prematurity refers to babies born before 37 weeks of gestation that through technological advances survival is increasing, since most of them are referred to the Neonatal Intensive Care Unit (NICU). Hemodynamic monitoring is of fundamental importance in the care provided to critically ill patients and mechanical ventilation (MV) is often used for the recovery and maintenance of newborns, especially premature infants with any pathology that causes cardiorespiratory failure. Considering this, it is necessary to look for ways to treat these newborns (NB), being the therapeutic positioning one of the simplest and most fundamental to reduce the consequences of the mechanical advantages of the respiratory system of newborns. Objective: To evaluate the hemodynamic repercussions in the various therapeutic positions in premature newborns under invasive mechanical ventilation. Method: A field study to be conducted will be randomized on an experimental, quantitative and descriptive character. It will be developed at the Santa Casa de Misericórdia do Pará Foundation (FSCMPa), in the Neonatal Intensive Care Unit. The population to be evaluated will be preterm infants with gestational age ≤37 weeks, on invasive mechanical ventilation, with no congenital malformations, with the diagnosis of intracranial hemorrhage and that those responsible, after being informed, authorized to participate in the research. Being excluded the preterm infants without legal companion, who are affected by any unfavorable clinical condition, which makes the change of unfeasible position, children with neuromuscular diseases, tracheostomized. A sample will be randomly selected in groups: Prono Group (GP), Supine Group (GS) and Lateral Decubitus Group (GDL). The decubitus to be adopted for each research subject will then be registered by the researcher in a specific form, recording as respiratory cardiological responses: respiratory rate (RR), heart rate (HR) and peripheral oxygen saturation (SPO2), temperature (T) and pressure blood pressure (BP). Such clinical responses will be noted prior to NB positioning, then positioned according to the group to which they will belong for 30 minutes, and then there will be another selection of vital signs.

Conditions

Therapeutic Position; Hemodynamics

Keywords

Premature newborn; Patient Positioning; Mechanical ventilation

Outcome Measures

Primary Outcomes (5)

• Vital sign of respiratory rate (rpm) will be measured before and after in different therapeutic positions of premature newborns under invasive mechanical ventilation.

  The respiratory rate (irpm) will be checked on the mechanical ventilator, noted before the positioning of premature newborns. Next, the newborns will be positioned according to the group and then there will be a recheck of the respiratory rate.

  Each newborn will be evaluated for only two weeks, being evaluated once a day, in the morning shift.

• Heart rate vital sign (bpm) will be measured before and after at different therapeutic positions of premature newborns under invasive mechanical ventilation.

  The heart rate (bpm) will be checked on the multiparametric vital signs monitor with a value verified by means of electrodes adhered to the patients' chest, noted before the positioning of the premature newborns. Next, the newborns will be positioned according to the group and then there will be a new heart rate check.

  Each newborn will be evaluated for only two weeks, being evaluated once a day, in the morning shift.

• Vital sign of peripheral oxygen saturation (percentage) will be measured before and after in different therapeutic positions of premature newborns under invasive mechanical ventilation.

  Peripheral oxygen saturation (percentage) will be verified in the multiparametric vital signs monitor with a value verified through the finger oximeter, noted before the positioning of the premature newborns. Next, the newborns will be positioned according to the group and then there will be a new check for peripheral oxygen saturation.

  Each newborn will be evaluated for only two weeks, being evaluated once a day, in the morning shift.

• Vital sign of temperature (degree Celsius) will be measured before and after in different therapeutic positions of preterm newborns under invasive mechanical ventilation.

  The temperature (degree Celsius) will be checked in the multiparametric vital signs monitor with a value verified by means of a sensor attached to the patient's axillary region, noted before the positioning of the premature newborns. Next, the newborns will be positioned according to the group they and then there will be a new temperature check.

  Each newborn will be evaluated for only two weeks, being evaluated once a day, in the morning shift.

• Blood pressure vital sign (mmHg) will be measured before and afterat different therapeutic positions of premature newborns under invasive mechanical ventilation.

  Blood pressure (mmHg) will be checked on the multiparametric vital signs monitor with a value verified by means of a pressure cuff placed on the patient's upper limb, noted before the positioning of the premature newborns. Next, the newborns will be positioned according to the group and then there will be a new blood pressure check.

  Each newborn will be evaluated for only two weeks, being evaluated once a day, in the morning shift.

Study Arms (3)

Supine Group (SG)

EXPERIMENTAL

Procedure: THERAPEUTIC POSITIONS

Prone Group (PG)

EXPERIMENTAL

Procedure: THERAPEUTIC POSITIONS

Lateral Decubitus Group (LDG)

EXPERIMENTAL

Procedure: THERAPEUTIC POSITIONS

Interventions

THERAPEUTIC POSITIONS PROCEDURE

Therapeutic positioning includes placing infants in prone (prone), supine, side (lateral) decubitus, using restraint devices to provide support, reassurance and physiological stability.

Lateral Decubitus Group (LDG); Prone Group (PG); Supine Group (SG)

Eligibility Criteria

• Age: 1 Day - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• PTNB with GA ≤37 weeks
• In ventilation invasive mechanics
• With absence of congenital malformations
• With absence a diagnosis of intracranial hemorrhage
• That the guardians after being informed, authorized to participate in the research

You may not qualify if:

• PTNB without a legal companion
• Who are affected by some unfavorable clinical condition that makes it impossible to change position
• Children with neuromuscular diseases
• Tracheostomized

Sponsors & Collaborators

• Amazon University: lead

Study Sites (1)

Paulo Eduardo Santos Avila

Belém, Pará, 66040-045, Brazil

Location

Related Publications (6)

• DE CARVALHO MORSCH, A. L. B. et al. Análise das repercussões clínicas da aplicação da posição prona em prematuros sem doença pulmonar. ERSPECTIVA, Erechim. v. 42, Edição Especial, p. 07-14, março, 2018.

  BACKGROUND

• DE CORDOBA LANZA, F.; BARCELLOS, P.G.; DAL CORSO, S. Benefícios do decúbito ventral associado ao CPAP em recém-nascidos prematuros. Fisioterapia e Pesquisa, v. 19, n. 2, p. 135-140, 2012.

  BACKGROUND

• DE SÁ, F. E. et al. Estudo sobre os efeitos fisiológicos da técnica de aumento do fluxo expiratório lento em prematuros. Fisioterapia & Saúde Funcional, v. 1, n. 1, p. 16-21, 2012.

  BACKGROUND

• Oliveira TG, Rego MA, Pereira NC, Vaz LO, Franca DC, Vieira DS, Parreira VF. Prone position and reduced thoracoabdominal asynchrony in preterm newborns. J Pediatr (Rio J). 2009 Sep-Oct;85(5):443-8. doi: 10.2223/JPED.1932. English, Portuguese.

  PMID: 19830358 BACKGROUND

• Ramada NC, Almeida Fde A, Cunha ML. Therapeutic touch: influence on vital signs of newborns. Einstein (Sao Paulo). 2013 Dec;11(4):421-5. doi: 10.1590/s1679-45082013000400003.

  PMID: 24488378 BACKGROUND

• Hough JL, Johnston L, Brauer SG, Woodgate PG, Pham TM, Schibler A. Effect of body position on ventilation distribution in preterm infants on continuous positive airway pressure. Pediatr Crit Care Med. 2012 Jul;13(4):446-51. doi: 10.1097/PCC.0b013e31822f18d9.

  PMID: 21926660 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: December 6, 2021
• Study Start: May 6, 2020
• Primary Completion: October 1, 2020
• Study Completion: January 15, 2021
• Last Updated: December 6, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)