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Vital SignsNCT05868980

The Effect of Postnatal Lying Position on Cerebral Oxygenation in Newborns

An observational study of Vital Signs, run by Dr. Behcet Uz Children's Hospital 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

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. Read more about this study

Who is it for?
Ages 2 to 10 minutesHealthy volunteers can take part
Conditions the study is for
Vital Signs
What is being tested?
vital signs by postpartum position
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2019to 1 Jun 2019
Phase
Observational
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 2 to 10 minutes
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: newborn

Who may be able to join

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

Who cannot join

  • Vaginal birth

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ege University Faculty of Medicine, Department of Child Health and Disease, Neonatal Department

    Izmır

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

This was a prospective, randomized, observational study performed in 2 months by the Newborn Department in the Delivery Room of the Department of Obstetrics and Gynecology where approximately 3,500 infants are delivered annually. Stabilization followed the NRP guideline and is implemented by a neonatology fellow and three pediatric assistants with NRP certificates. Single, term, appropriate for gestational age (AGA) babies who did not need resuscitation and babies in whom skin-to-skin contact cannot be applied were included in the study. Vaginal births were not included, only babies born with cesarean sectio (CS) and could not not exposed to early skin-to-skin contact were included.

Spinal anesthesia was used for the mothers for CS, mother was not given oxygen therapy until the baby came out. Parents were informed of the study prior to birth and written consent was obtained from those who were willing to participate. The babies were randomized by opening of envelopes containing positional codes and were placed supine, on the right or left side, or prone (15/group).

  1. Infant positioning: Infants were placed under radiant heat for 10 min in the various positions; first-step resuscitation was performed in a routine manner. Infants with a need for positive pressure ventilation were excluded; all were placed supine.
  2. Medical records and vital parameters: All evaluations commenced 30 s after delivery and terminated at 10 min. For each infant, the 1st and 5th min Apgar scores were calculated by the same person, and the heart rate (HR), pulse oximetry, and perfusion index (PI) were recorded at 2nd, 5th, and 10th min using a Masimo Radical-7 pulse co-oximetry with an adhesive sensor. The probe was placed preductally (on the right wrist) and then connected to the oximetry. The fraction of inspired oxygen (FiO2) was only 0.21 ("room-air") during all the stabilization period. In line with the NRP 2015 guideline, aspiration was not routinely performed in the delivery room; the number of times that touch stimulation was required and the tactile stimulus time were recorded. Although electrocardiography (ECG) recommended in the latest guidelines and reads heart rate much faster, pulse oximetry had to be used in our study because the relationship between position and saturation and cerebral oximetry was evaluated.
  3. Cerebral oxygenation: Near-infrared spectroscopy (NIRS), which measures tissue oxygenation noninvasively, was used to evaluate cerebral oxygenation; the mean values at 5th and 10th min were recorded using a Covidien INVOS 5100C instrument. The cerebral regional cerebral oxygen saturation (rScO2) is the ratio of cerebral oxygenated hemoglobin (CHbO2) to the total oxygen bound to cerebral hemoglobin (CHb) and CHbO2 (rScO2 = CHbO2/CHb + CHbO2) (1). The rScO2 is the mean oxygen saturation of cerebral arterial, venule, and capillary blood; the venule data is predominate (2). Infrared light reveals the extent of saturation of the so-called watershed zone (a mixture of 33% arterial and 67% venous blood at a depth of 1-1,5 cm) (3). The NIRS probe was placed on both sides of the frontal lobe; the probe was cleaned before placement. The first measured value served as the basal value; rScO2 changes were then recorded at 2-s intervals to 60 s and the mean calculated. The cerebral rScO2 is normally 50-80, but may vary by 10-20% at any time (4). A decrease >20% for patients with a basal cerebral rScO2 value >50 and a decrease >15% for those with a basal cerebral rScO2 <50 indicate cerebral ischemia (5). Data were captured at 0.1 Hz and collected for 10 min, after application in each position consequently. Cerebral fractional oxygen extraction (cFOE) was calculated for 5th and 10th min average as ( (SpO2-rScO2)/SpO2 ) (SpO2: pulse oximetry oxygen saturation) for each position, which reflects the balance between oxygen delivery and consumption in the tissue (6). An infant/pediatric sensor (Covidien INVOS 5100C) costs between $110 and $140 each. No outside funding was used for the budget in this study. Within the budget and time period, the maximum number of patients enrolled in the study.
  4. Sample Size: In the investigators' center, monthly birth rate is 300 and since our hospital is the largest perinatology center in our region; the number of births with maternal and neonatal problems is high. When the investigators evaluated our records for the number of infants who were born > 37 GA with CS under spinal anesthesia and did not require any resuscitation efforts; the number was approximately 15 per month. (P=0.05) with a 2-sided a error of 5% and power of 80%, a total sample size of 37 total was required.
  5. Statistical Analyses:

SPSS 25.0 (IBM Corporation, Armonk, New York, United States) and PAST 3 (Hammer, Ø., Harper, D.A.T., Ryan, P.D. 2001. Paleontological statistics) programs were used in the analysis of the variables. The conformity of univariate data to normal distribution was evaluated with the Shapiro-Wilk francia test, while homogeneity of variance was evaluated with the Levene test. Mardia for the conformity of multivariate data to normal distribution; while the (Dornik and Hansen omnibus) test was used, the Box-M test was used for variance homogeneity. In the comparison of more than two groups according to quantitative data, Fisher's Least Significant Difference (LSD) tests were used for One-Way Anova post hoc analysis, one of the parametric methods, Kruskal-Wallis H Test, which is one of the nonparametric tests, was used with the results of Monte Carlo simulation technique, and Dunn's Test was used for Post Hoc analyses. The Paired-Samples T test was tested using Bootstrap results, while the Wilcoxon Signed Ranks Test was tested using the monte carlo simulation method to compare two replicate measurements of dependent quantitative variables with each other. While Friedman's Two-Way test was tested using the monte carlo simulation method to test the variables with more than two repeated measurements and to examine the interaction according to the groups, the General Linear Model-Repeated Anova test from parametric methods was used, and the LSD test was used for Post Hoc analyses. In the comparison of categorical variables with each other, Fisher-Freeman-Holton test was tested with Monte Carlo Simulation technique. While quantitative variables were expressed as mean (standard deviation) and Median (Percentile 25 / Percentile 75) in the tables, categorical variables were shown as n (%). The variables were analyzed at 95% confidence level, and a p value less than 0.05 was considered significant.

Conditions
Vital Signs
Being tested
vital signs by postpartum position
Keywords
delivery room, neonatal resuscitation, postnatal adaptation, cerebral oxygenation

What participants receive

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

  • vital signs by postpartum positionOther

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

Study groups in NCT05868980
Study groupRoleWhat they receive
supinesupine position: Evaluation position for the first 10 minutes after birth
Receives: Other: vital signs by postpartum position
right-sideright-side position: Evaluation position for the first 10 minutes after birth
Receives: Other: vital signs by postpartum position
left-sideleft-side position: Evaluation position for the first 10 minutes after birth
Receives: Other: vital signs by postpartum position
proneprone position: Evaluation position for the first 10 minutes after birth
Receives: Other: vital signs by postpartum position

What is being measured

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

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

    near infrared spectroscopy

    Measured: 10 minutes

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

    fractional oxygean extraction

    Measured: 10 minutes

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

    heart rate

    Measured: 10 minutes

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

    pulseoximeter

    Measured: 10 minutes

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

    perfusion index

    Measured: 10 minutes

  6. Apgar scores for each position at delivery roomat delivery room

    apgar scores

    Measured: 5 minutes

Timeline

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

  1. First posted22 May 2023
  2. Study start1 Feb 2019
  3. Primary completion1 Apr 2019
  4. Study completion1 Jun 2019

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05868980
Sponsor's protocol ID
2018/193
Status last verified
May 2023
First submitted
31 Mar 2023
Last updated
22 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 1489116
  • 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.

    PubMed 17906392
  • Brodsky JB. What intraoperative monitoring makes sense? Chest. 1999 May;115(5 Suppl):101S-105S. doi: 10.1378/chest.115.suppl_2.101s.

    PubMed 10331341
  • 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.

    PubMed 20497559
  • 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.

    PubMed 11020747
  • 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.

    PubMed 17377413

Questions about this trial

What is this clinical trial studying?

An observational study of Vital Signs, run by Dr. Behcet Uz Children's Hospital 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 1 inclusion and 1 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 22 May 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?

near infrared spectroscopy (NIRS) for each position at delivery room (time frame: 10 minutes). The study lists 6 primary outcomes in all. 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 NCT05868980, which also lists 6 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 22 May 2023.

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