Neonatal Resuscitation
Conditions
Keywords
Neonatal resuscitation, Stimulation, Asphyxia
Brief summary
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.
Interventions
PROCEDUREBack rub stimulation
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.
PROCEDUREFoot flicks stimulation
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.
Sponsors
Jerry Ictho
John Bosco Nsubuga
Jesca Ameo
Giovanni Putoto
Peter Lochoro
University Hospital Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Only statistician will be masked to tretament
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 10 Minutes
Healthy volunteers
No
Inclusion criteria
1. Newly born infants who are apneic (not crying) immediately after birth (and) 2. Expected birthweight \> 1500 g (and) 3. Parental consent
Exclusion criteria
1. Still births 2. Twins 3. Major congenital malformations (i.e. congenital cardiac malformation, pulmonary hypoplasia, major spina bifida, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of babies needing positive pressure ventilation | 2 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of initiation of face-mask ventilation | 5 minutes | — |
| Time of duration of face-mask ventilation | 20 minutes | — |
| Time to first cry | 20 minutes | — |
| Apgar score at 5 minutes | 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 |
| 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 | 7 days | The grade of encephalopathy will be measured according to a modified Sarnat and Sarnat classification |
| Percentage of deaths | 7 days | — |
Countries
Uganda
Contacts
Primary ContactDaniele Trevisanuto, MD
Backup ContactPeter Lochoro, MD
Outcome results
None listed