Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes

The aim of this study was to assess whether administration of oxytocin intrapartum (Oxt) has any effect on Neonatal Primitive Reflexes (RNP) and if dose dependent. The secondary objective is to assess the effects on exclusive breastfeeding at 3 months

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Key information

Conditions

Bonding Behavior Breast Feeding Breastfeeding Feeding Behavior Newborn Oxytocin Perinatal

Age range

1 day–4 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Puerta de Hierro-Majadahonda

Madrid, 28220, Spain

About this study

Patients and Methods Prospective case-control study performed in a tertiary hospital. Cases: mother-child dyads in which Oxt had been administered during the birth process (n = 53). Controls: mother-child dyads without Oxt (n = 45). The RNP were recorded with a camcorder in biological nurturing position. An observer blinded to the group and the dose of Oxt codified the RNP (reach/not reached). To assess the type of breastfeeding telephone call was made at 3 months old RN.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy singleton term infant delivered vaginally with Apgar at 5 min> 7;
Expressed desire to administer during pregnancy breastfeeding;
Signed informed consent

Exclusion criteria

Preterm neonate;
Fetal chromosomal or other abnormalities diagnosed in utero to modify their adaptation to extrauterine environment;
Hospitalization of the mother in ICU;
Hospitalization in the following 48 hours neonate at birth;
Wish to artificial feeding before parturition;
Language difficulties;
Completion of caesarean delivery

Treatment and study plan

Oxytocin

Drug

Comparison of Primitive Newborn Reflexes between those exposed or not to Oxytocin

Primary outcomes

Expression of Neonatal Primitive Reflexes (RNP) are modified by administration of Oxytocin during delivery.

Time frame: 72 hours

Neonatal Primitive Reflexes studied were: 1) Endogenous: hand to mouth, extension / flexion of fingers, mouth open, tongue extrusion, arm circular motion, circular motion of the leg, flex foot / hand, 2) Antigravity: raise the head, 3) Motors: turn your head, nod, plantar pressure, Babinski, and 4) Rhythmic: suction, jaw movement and swallowing.

An observer, blinded to the study group and the dose administered of Oxytocin, valued recordings, analyzing the state of consciousness at the beginning of the recording as Brazelton scale and form RNP dichotomous coding (achieved / not achieved).

Secondary outcomes

Oxytocin intrapartum may have adverse influence on exclusive breastfeeding at 3 months.

Time frame: 6 months

To assess the type of feeding (exclusive breastfeeding versus other) at different time points (discharge, one month and three months) a telephone call was conducted at 3 months old of the newborn.

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jul 3, 2013
Registry last updated: Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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