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| Name | Class |
|---|---|
| Jerry Ictho | UNKNOWN |
| John Bosco Nsubuga | UNKNOWN |
| Jesca Ameo | UNKNOWN |
| Giovanni Putoto |
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Physical stimulation is the most common intervention during neonatal stabilization/resuscitation at birth and is recommended by neonatal resuscitation guidelines in high as well low-income settings. Two modalities of stimulation (back rubs or foot flicks) are recommended.
This is a single center, unblinded, randomized superiority trial. Immediately after birth, all "not crying" infants will be randomly assigned in a 1:1 ratio to two different modes of stimulation (back rubs or foot flicks). Exclusion criteria will be stillbirths and presence of major neonatal malformations. The primary outcome measure will be the need for FMV. Secondary outcome measures will include Apgar score at 5 minutes, time of initiation and duration of FMV, time to first cry (defined as the first audible cry spontaneously emitted by the infant), death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life or at discharge, admission to special care, and procedure-associated complications.
The results of the present study will help to identify the most appropriate mode for stimulating the apneic newly infants in delivery room. In clinical practice, this information is very relevant because effective stimulation at birth will elicit spontaneous respiratory in a certain percentage of apneic neonates avoiding the need for positive pressure ventilation and, possibly, further advanced resuscitative maneuvers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Back rub stimulation | Experimental |
| |
| Foot flicks stimulation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Back rub stimulation | Procedure | Immediately after birth, all infants with an expected birthweight >1500 g who have been dried and remain apneic (not crying) will receive physical stimulation (back rubs). Stimulation can be repeated at maximum two or three times for about 3-5 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of babies needing positive pressure ventilation | 2 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Apgar score at 5 minutes | Apgar score is a scale from 0 (very bad) to 10 (very good) that classify the clinical condition of the neonates during the first minutes of life | 5 minutes |
| Time of initiation of face-mask ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniele Trevisanuto, MD | Contact | +390498213545 | daniele.trevisanuto@unipd.it | |
| Peter Lochoro, MD | Contact | +256312260097 | p.lochoro@cuamm.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matany Hospital | Recruiting | Moroto | Karamoja | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28421171 | Background | Dekker J, Martherus T, Cramer SJE, van Zanten HA, Hooper SB, Te Pas AB. Tactile Stimulation to Stimulate Spontaneous Breathing during Stabilization of Preterm Infants at Birth: A Retrospective Analysis. Front Pediatr. 2017 Apr 3;5:61. doi: 10.3389/fped.2017.00061. eCollection 2017. | |
| 15036740 | Result | Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. doi: 10.1016/j.resuscitation.2003.10.002. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001237 | Asphyxia |
| ID | Term |
|---|---|
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| Peter Lochoro | UNKNOWN |
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Only statistician will be masked to tretament
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|
| Foot flicks stimulation | Procedure | Immediately after birth, all infants with an expected birthweight >1500 g who have been dried and remain apneic (not crying) will receive physical stimulation (foot flicks). Stimulation can be repeated at maximum two or three times for about 3-5 seconds. |
|
| 5 minutes |
| Time of duration of face-mask ventilation | 20 minutes |
| Time to first cry | 20 minutes |
| Percentage of deaths | 7 days |
| Peercentage of babies admitted to special care | 2 hours |
| Percentage of procedure-associated complications | 3 days |
| Percentage of babies with moderate to severe hypoxic-ischemic encephalopathy | The grade of encephalopathy will be measured according to a modified Sarnat and Sarnat classification | 7 days |
| 20483522 | Result | Voogdt KG, Morrison AC, Wood FE, van Elburg RM, Wyllie JP. A randomised, simulated study assessing auscultation of heart rate at birth. Resuscitation. 2010 Aug;81(8):1000-3. doi: 10.1016/j.resuscitation.2010.03.021. Epub 2010 May 18. |
| 30236090 | Result | Pietravalle A, Cavallin F, Opocher A, Madella S, Cavicchiolo ME, Pizzol D, Putoto G, Trevisanuto D. Neonatal tactile stimulation at birth in a low-resource setting. BMC Pediatr. 2018 Sep 20;18(1):306. doi: 10.1186/s12887-018-1279-4. |
| 28600392 | Result | Gaertner VD, Flemmer SA, Lorenz L, Davis PG, Kamlin COF. Physical stimulation of newborn infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2018 Mar;103(2):F132-F136. doi: 10.1136/archdischild-2016-312311. Epub 2017 Jun 9. |
| 26477415 | Result | Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available. |
| 28419084 | Result | Kamath-Rayne BD, Berkelhamer SK, Kc A, Ersdal HL, Niermeyer S. Neonatal resuscitation in global health settings: an examination of the past to prepare for the future. Pediatr Res. 2017 Aug;82(2):194-200. doi: 10.1038/pr.2017.48. Epub 2017 May 24. |
| 26473001 | Result | Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available. |
| 34438002 | Derived | Cavallin F, Lochoro P, Ictho J, Nsubuga JB, Ameo J, Putoto G, Trevisanuto D. Back rubs or foot flicks for neonatal stimulation at birth in a low-resource setting: A randomized controlled trial. Resuscitation. 2021 Oct;167:137-143. doi: 10.1016/j.resuscitation.2021.08.028. Epub 2021 Aug 23. |
| Related Info | View source |