The Effect of Postnatal Lying Position on Cerebral Oxygenation in Newborns

NCT05868980 | Completed DMC

• 1 other identifier: 2018/193
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In the international delivery room guidelines, it is not specified which position is optimal for the baby stabilization. Here, the investigators want to evaluate the effects of the positions on postnatal adaptation and cerebral oxygenation in the delivery room of infants who did not require resuscitation. Infants will be randomly stabilized in the supine, right-side, left-side and prone positions (60 babies in all, 15/position). The investigators will record the 1st and 5th min Apgar scores and the heart rate, pulse oximetry and perfusion index at 2nd,5th and 10thmin. Near-infrared spectroscopy will be used to assess cerebral regional oxygen saturation.

Conditions

Vital Signs

Keywords

delivery room; neonatal resuscitation; postnatal adaptation; cerebral oxygenation

Outcome Measures

Primary Outcomes (6)

• near infrared spectroscopy (NIRS) for each position at delivery room

  near infrared spectroscopy

  10 minutes

• fractional oxygean extraction (FOE) for each position at delivery room

  fractional oxygean extraction

  10 minutes

• postnatal adaptation on vital parameters as heart rate for each position at delivery room

  heart rate

  10 minutes

• postnatal adaptation on vital parameters as pulseoximeter for each position at delivery room

  pulseoximeter

  10 minutes

• postnatal adaptation on vital parameters as perfusion index for each position at delivery room

  perfusion index

  10 minutes

• Apgar scores for each position at delivery roomat delivery room

  apgar scores

  5 minutes

Study Arms (4)

supine

supine position: Evaluation position for the first 10 minutes after birth

Other: vital signs by postpartum position

right-side

right-side position: Evaluation position for the first 10 minutes after birth

Other: vital signs by postpartum position

left-side

left-side position: Evaluation position for the first 10 minutes after birth

Other: vital signs by postpartum position

prone

prone position: Evaluation position for the first 10 minutes after birth

Other: vital signs by postpartum position

Interventions

vital signs by postpartum position OTHER

Evaluation of vital signs and NIRS values in 4 different positions after birth

left-side; prone; right-side; supine

Eligibility Criteria

• Age: 2 Minutes - 10 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

newborn

You may qualify if:

• born with cesarean sectio (CS) could not exposed to early skin-to-skin contact

You may not qualify if:

• Vaginal birth

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Department

Izmır, Turkey (Türkiye)

Location

Related Publications (6)

• Mutoh T, Guest RJ, Lamm WJ, Albert RK. Prone position alters the effect of volume overload on regional pleural pressures and improves hypoxemia in pigs in vivo. Am Rev Respir Dis. 1992 Aug;146(2):300-6. doi: 10.1164/ajrccm/146.2.300.

  PMID: 1489116 RESULT

• Hou X, Ding H, Teng Y, Zhou C, Tang X, Li S, Ding H. Research on the relationship between brain anoxia at different regional oxygen saturations and brain damage using near-infrared spectroscopy. Physiol Meas. 2007 Oct;28(10):1251-65. doi: 10.1088/0967-3334/28/10/010. Epub 2007 Sep 28.

  PMID: 17906392 RESULT

• Brodsky JB. What intraoperative monitoring makes sense? Chest. 1999 May;115(5 Suppl):101S-105S. doi: 10.1378/chest.115.suppl_2.101s.

  PMID: 10331341 RESULT

• Baikoussis NG, Karanikolas M, Siminelakis S, Matsagas M, Papadopoulos G. Baseline cerebral oximetry values in cardiac and vascular surgery patients: a prospective observational study. J Cardiothorac Surg. 2010 May 24;5:41. doi: 10.1186/1749-8090-5-41.

  PMID: 20497559 RESULT

• Samra SK, Dy EA, Welch K, Dorje P, Zelenock GB, Stanley JC. Evaluation of a cerebral oximeter as a monitor of cerebral ischemia during carotid endarterectomy. Anesthesiology. 2000 Oct;93(4):964-70. doi: 10.1097/00000542-200010000-00015.

  PMID: 11020747 RESULT

• Naulaers G, Meyns B, Miserez M, Leunens V, Van Huffel S, Casaer P, Weindling M, Devlieger H. Use of tissue oxygenation index and fractional tissue oxygen extraction as non-invasive parameters for cerebral oxygenation. A validation study in piglets. Neonatology. 2007;92(2):120-6. doi: 10.1159/000101063. Epub 2007 Mar 23.

  PMID: 17377413 RESULT

Study Officials

• ruya colak

  Dr Behçet Uz Children's Diseases and Surgery Training and Research Hospital, Neonatal Department

  STUDY CHAIR

• demet terek

  Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Department

  STUDY CHAIR

• ozge altun koroglu

  Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Department

  STUDY CHAIR

• sebnem calkavur

  Dr Behçet Uz Children's Diseases and Surgery Training and Research Hospital, Neonatal Department

  STUDY CHAIR

• mehmet yalaz

  Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Department

  STUDY CHAIR

• nilgun kultursay

  Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Department

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: May 22, 2023
• Study Start: February 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

TU (1)